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    <title>CHMP</title>
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    <item>
      <title>Moderna’s combo flu/COVID vaccine gets thumbs up in EU </title>
      <description>
        <![CDATA[The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/729260</guid>
      <pubDate>Fri, 27 Feb 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/729260-modernas-combo-flu-covid-vaccine-gets-thumbs-up-in-eu</link>
    </item>
    <item>
      <title>Charity bringing to EU market gene therapy spurned by pharma</title>
      <description>
        <![CDATA[Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.]]>
      </description>
      <guid>http://www.bioworld.com/articles/726170</guid>
      <pubDate>Fri, 14 Nov 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/726170-charity-bringing-to-eu-market-gene-therapy-spurned-by-pharma</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Research-and-science/Transparent-capsule-with-DNA-and-cells.webp?t=1741982166" type="image/jpeg" medium="image" fileSize="142308">
        <media:title type="plain">Transparent capsule with DNA and cells</media:title>
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      <title>Mixed EMA news for Sanofi: Wayrilz yay, Rezurock nay</title>
      <description>
        <![CDATA[There was a curate’s egg for Sanofi SA from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use, with a recommendation to approve one of the French pharma’s drugs – and the rejection of another.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725231</guid>
      <pubDate>Fri, 17 Oct 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725231-mixed-ema-news-for-sanofi-wayrilz-yay-rezurock-nay</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Misc/Green-checkmark-and-red-X.webp?t=1729717860" type="image/jpeg" medium="image" fileSize="137052">
        <media:title type="plain">Green checkmark and red X</media:title>
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      <title>US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors</title>
      <description>
        <![CDATA[The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724562</guid>
      <pubDate>Tue, 23 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724562-us-fda-clears-one-minute-keytruda-sc-injection-for-solid-tumors</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Keytruda-Qlex3.webp?t=1758572923" type="image/jpeg" medium="image" fileSize="270416">
        <media:title type="plain">Keytruda Qlex</media:title>
        <media:description type="plain">Credit: Merck &amp;amp; Co. Inc.</media:description>
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    </item>
    <item>
      <title>US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors</title>
      <description>
        <![CDATA[The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724372</guid>
      <pubDate>Mon, 22 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724372-us-fda-clears-one-minute-keytruda-sc-injection-for-solid-tumors</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Keytruda-Qlex3.webp?t=1758572923" type="image/jpeg" medium="image" fileSize="270416">
        <media:title type="plain">Keytruda Qlex</media:title>
        <media:description type="plain">Credit: Merck &amp;amp; Co. Inc.</media:description>
      </media:content>
    </item>
    <item>
      <title>CHMP recommends EU approval of Bayer’s Lynkuet for hot flashes</title>
      <description>
        <![CDATA[Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724310</guid>
      <pubDate>Fri, 19 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724310-chmp-recommends-eu-approval-of-bayers-lynkuet-for-hot-flashes</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Person-holding-pills-and-glass-of-water.webp?t=1744924970" type="image/jpeg" medium="image" fileSize="128864">
        <media:title type="plain">Person holding pills and glass of water</media:title>
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    <item>
      <title>Europe approves Bio-Thera’s Stelara biosimilar</title>
      <description>
        <![CDATA[Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723859</guid>
      <pubDate>Tue, 02 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723859-europe-approves-bio-theras-stelara-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/European-flag-vaccine.webp?t=1650922336" type="image/png" medium="image" fileSize="294231">
        <media:title type="plain">European flag, vial, syringe</media:title>
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    <item>
      <title>Europe approves Bio-Thera’s Stelara biosimilar</title>
      <description>
        <![CDATA[Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723329</guid>
      <pubDate>Wed, 27 Aug 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723329-europe-approves-bio-theras-stelara-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/European-flag-vaccine.webp?t=1650922336" type="image/png" medium="image" fileSize="294231">
        <media:title type="plain">European flag, vial, syringe</media:title>
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    <item>
      <title>CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla</title>
      <description>
        <![CDATA[After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.]]>
      </description>
      <guid>http://www.bioworld.com/articles/722432</guid>
      <pubDate>Fri, 25 Jul 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/722432-chmp-rejects-sareptas-elevidys-changes-mind-on-lillys-kisunla</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/EU-flag-syringe-capsules.webp?t=1631902697" type="image/png" medium="image" fileSize="422232">
        <media:title type="plain">EU flag, syringe, capsules</media:title>
      </media:content>
    </item>
    <item>
      <title>CHMP recommends approval of Rezdiffra, Ogsiveo and others</title>
      <description>
        <![CDATA[One year after the FDA’s nod, the EMA is following on and recommending conditional approval of Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) as the first drug in Europe for treating noncirrhotic metabolic dysfunction-associated steatohepatitis.]]>
      </description>
      <guid>http://www.bioworld.com/articles/721433</guid>
      <pubDate>Fri, 20 Jun 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/721433-chmp-recommends-approval-of-rezdiffra-ogsiveo-and-others</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Rezdiffra.webp?t=1710516240" type="image/jpeg" medium="image" fileSize="71595">
        <media:title type="plain">Rezdiffra </media:title>
        <media:description type="plain">Credit: Madrigal Pharmaceuticals Inc.</media:description>
      </media:content>
    </item>
    <item>
      <title>Yanked from the market in 2022, GSK’s Blenrep gets an EU redo</title>
      <description>
        <![CDATA[GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.]]>
      </description>
      <guid>http://www.bioworld.com/articles/720616</guid>
      <pubDate>Fri, 23 May 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720616-yanked-from-the-market-in-2022-gsks-blenrep-gets-an-eu-redo</link>
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        <media:title type="plain">Antibody-drug conjugate</media:title>
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    </item>
    <item>
      <title>Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP</title>
      <description>
        <![CDATA[Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.]]>
      </description>
      <guid>http://www.bioworld.com/articles/719658</guid>
      <pubDate>Mon, 28 Apr 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/719658-argenxs-vyvgart-camurus-oczyesa-among-16-recommended-by-chmp</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Vyvgart-Hytrulo.webp?t=1745868605" type="image/jpeg" medium="image" fileSize="95292">
        <media:title type="plain">Vyvgart Hytrulo</media:title>
        <media:description type="plain">Credit: Argenx </media:description>
      </media:content>
    </item>
    <item>
      <title>Leqembi gets another thumbs-up amid CHMP February recommendations</title>
      <description>
        <![CDATA[The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved]]>
      </description>
      <guid>http://www.bioworld.com/articles/717792</guid>
      <pubDate>Fri, 28 Feb 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/717792-leqembi-gets-another-thumbs-up-amid-chmp-february-recommendations</link>
    </item>
    <item>
      <title>Leqembi review stalls again at European regulator</title>
      <description>
        <![CDATA[EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.]]>
      </description>
      <guid>http://www.bioworld.com/articles/716868</guid>
      <pubDate>Fri, 31 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716868-leqembi-review-stalls-again-at-european-regulator</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EMA-icons.webp?t=1619205754" type="image/png" medium="image" fileSize="406915">
        <media:title type="plain">EMA icons</media:title>
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    </item>
    <item>
      <title>Welireg, Emcitate among drugs EMA recommends for approval</title>
      <description>
        <![CDATA[The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.]]>
      </description>
      <guid>http://www.bioworld.com/articles/715340</guid>
      <pubDate>Fri, 13 Dec 2024 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/715340-welireg-emcitate-among-drugs-ema-recommends-for-approval</link>
    </item>
    <item>
      <title>Eisai wins on appeal: CHMP recommends Leqembi for Alzheimer’s</title>
      <description>
        <![CDATA[The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.]]>
      </description>
      <guid>http://www.bioworld.com/articles/714560</guid>
      <pubDate>Fri, 15 Nov 2024 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/714560-eisai-wins-on-appeal-chmp-recommends-leqembi-for-alzheimers</link>
    </item>
    <item>
      <title>CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib</title>
      <description>
        <![CDATA[The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.]]>
      </description>
      <guid>http://www.bioworld.com/articles/713664</guid>
      <pubDate>Mon, 21 Oct 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/713664-chmp-nods-for-korjuny-alhemo-no-again-for-translarna-masitinib</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/EU-flag-syringe-capsules.webp?t=1631902697" type="image/png" medium="image" fileSize="422232">
        <media:title type="plain">EU flag, syringe, capsules</media:title>
      </media:content>
    </item>
    <item>
      <title>EMA’s CHMP recommends Hympavzi for hemophilia, Elahere for cancer</title>
      <description>
        <![CDATA[For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712717</guid>
      <pubDate>Mon, 23 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712717-emas-chmp-recommends-hympavzi-for-hemophilia-elahere-for-cancer</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EMA-icons.webp?t=1619205754" type="image/png" medium="image" fileSize="406915">
        <media:title type="plain">EMA icons</media:title>
      </media:content>
    </item>
    <item>
      <title>Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now</title>
      <description>
        <![CDATA[Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712289</guid>
      <pubDate>Thu, 05 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712289-advanz-wins-stay-keeps-pbc-drug-ocaliva-on-europe-market-for-now</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/European-Union-flag-with-wooden-gavel.webp?t=1725567663" type="image/jpeg" medium="image" fileSize="204290">
        <media:title type="plain">European Union flag with wooden gavel</media:title>
      </media:content>
    </item>
    <item>
      <title>A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab</title>
      <description>
        <![CDATA[Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711081</guid>
      <pubDate>Tue, 30 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711081-a-chmp-thumbs-up-for-astellas-claudin182-zolbetuximab</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/EU-European-Union-Flag-Brussels.webp?t=1623187469" type="image/png" medium="image" fileSize="1249586">
        <media:title type="plain">EU flags in front of the Berlaymont building</media:title>
      </media:content>
    </item>
    <item>
      <title>EMA’s CHMP issues thumbs-down on Alzheimer’s drug Leqembi</title>
      <description>
        <![CDATA[The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710800</guid>
      <pubDate>Tue, 30 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710800-emas-chmp-issues-thumbs-down-on-alzheimers-drug-leqembi</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Leqembi.webp?t=1684787961" type="image/jpeg" medium="image" fileSize="142181">
        <media:title type="plain">Leqembi</media:title>
        <media:description type="plain">Credit: Eisai Co. Inc.</media:description>
      </media:content>
    </item>
    <item>
      <title>A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab</title>
      <description>
        <![CDATA[Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710782</guid>
      <pubDate>Mon, 29 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710782-a-chmp-thumbs-up-for-astellas-claudin182-zolbetuximab</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/Europe/EU-European-Union-Flag-Brussels.webp?t=1623187469" type="image/png" medium="image" fileSize="1249586">
        <media:title type="plain">EU flags in front of the Berlaymont building</media:title>
      </media:content>
    </item>
    <item>
      <title>ARIA swan song for Leqembi in EU? Eisai, Biogen appeal AD opinion</title>
      <description>
        <![CDATA[Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711040</guid>
      <pubDate>Fri, 26 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711040-aria-swan-song-for-leqembi-in-eu-eisai-biogen-appeal-ad-opinion</link>
    </item>
    <item>
      <title>PBC patients fight back in Europe on looming Ocaliva withdrawal</title>
      <description>
        <![CDATA[Those affected by primary biliary cholangitis (PBC) are fighting back against the recommendation by the EMA that the marketing authorization for Ocaliva (obeticholic acid), a second-line treatment used by 7,000 patients in Europe, be withdrawn. Earlier today, July 25, patients and their supporters staged a protest outside the European Commission building in Brussels to oppose EMA’s position that Ocaliva’s conditional license should be revoked.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710994</guid>
      <pubDate>Thu, 25 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710994-pbc-patients-fight-back-in-europe-on-looming-ocaliva-withdrawal</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Ocaliva.webp?t=1721939634" type="image/jpeg" medium="image" fileSize="83919">
        <media:title type="plain">Ocaliva</media:title>
      </media:content>
    </item>
    <item>
      <title>EMA takes negative view on masitinib; Ocaliva, Translarna out </title>
      <description>
        <![CDATA[Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710205</guid>
      <pubDate>Mon, 01 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710205-ema-takes-negative-view-on-masitinib-ocaliva-translarna-out</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EMA-icons.webp?t=1619205754" type="image/png" medium="image" fileSize="406915">
        <media:title type="plain">EMA icons</media:title>
      </media:content>
    </item>
    <item>
      <title>CHMP: Re-eval for Translarna; recommendation for Ixchiq, Cejemly</title>
      <description>
        <![CDATA[The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.]]>
      </description>
      <guid>http://www.bioworld.com/articles/709174</guid>
      <pubDate>Mon, 03 Jun 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/709174-chmp-re-eval-for-translarna-recommendation-for-ixchiq-cejemly</link>
    </item>
    <item>
      <title>Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar</title>
      <description>
        <![CDATA[South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.]]>
      </description>
      <guid>http://www.bioworld.com/articles/709004</guid>
      <pubDate>Tue, 28 May 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/709004-celltrions-omlyclo-gets-nod-as-europes-first-xolair-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Wood-approved-stamp-red.webp?t=1670969940" type="image/png" medium="image" fileSize="323015">
        <media:title type="plain">Red wooden approved stamp</media:title>
      </media:content>
    </item>
    <item>
      <title>Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar</title>
      <description>
        <![CDATA[South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.]]>
      </description>
      <guid>http://www.bioworld.com/articles/708966</guid>
      <pubDate>Fri, 24 May 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/708966-celltrions-omlyclo-gets-nod-as-europes-first-xolair-biosimilar</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Wood-approved-stamp-red.webp?t=1670969940" type="image/png" medium="image" fileSize="323015">
        <media:title type="plain">Red wooden approved stamp</media:title>
      </media:content>
    </item>
    <item>
      <title>Takeda’s Fruzaqla leads list of positive CHMP opinions</title>
      <description>
        <![CDATA[Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/708117</guid>
      <pubDate>Tue, 30 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/708117-takedas-fruzaqla-leads-list-of-positive-chmp-opinions</link>
    </item>
    <item>
      <title>Takeda’s Fruzaqla leads list of positive CHMP opinions</title>
      <description>
        <![CDATA[Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/708028</guid>
      <pubDate>Fri, 26 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/708028-takedas-fruzaqla-leads-list-of-positive-chmp-opinions</link>
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