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      <title>FDA clears IND for Harbour Biomed’s HBM-7004</title>
      <description>
        <![CDATA[Harbour Biomed has gained IND clearance from the FDA for HBM-7004, enabling the initiation of a first-in-human phase I trial in subjects with advanced solid tumors. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/730950</guid>
      <pubDate>Fri, 08 May 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730950-fda-clears-ind-for-harbour-biomeds-hbm-7004</link>
    </item>
    <item>
      <title>Arrivent’s MUC16/NaPi2b-targeted ADC gains IND clearance</title>
      <description>
        <![CDATA[Arrivent Biopharma Inc. has obtained IND clearance from the FDA for ARR-002 (AV-P138-ADC), an antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors. A phase I trial is expected to open in the second half of the year.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730948</guid>
      <pubDate>Fri, 08 May 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730948-arrivents-muc16-napi2b-targeted-adc-gains-ind-clearance</link>
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        <media:title type="plain">Female reproductive system and cancer cells</media:title>
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      <title>FDA slowdown on Tzield sBLA underlines CNPV questions</title>
      <description>
        <![CDATA[Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730970</guid>
      <pubDate>Thu, 07 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730970-fda-slowdown-on-tzield-sbla-underlines-cnpv-questions</link>
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        <media:title type="plain">FDA logo on textured paper</media:title>
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      <title>US FDA tries out 1-day inspections</title>
      <description>
        <![CDATA[Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730852</guid>
      <pubDate>Thu, 07 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730852-us-fda-tries-out-1-day-inspections</link>
    </item>
    <item>
      <title>Bio Korea 2026 kicks off with spotlight on oligonucleotides</title>
      <description>
        <![CDATA[Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730927</guid>
      <pubDate>Tue, 05 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730927-bio-korea-2026-kicks-off-with-spotlight-on-oligonucleotides</link>
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        <media:title type="plain">AI generated image for researcher developing antisense oligonucleotides</media:title>
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      <title>Bio Korea 2026: US policy risks shift to execution framework</title>
      <description>
        <![CDATA[Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730926</guid>
      <pubDate>Tue, 05 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730926-bio-korea-2026-us-policy-risks-shift-to-execution-framework</link>
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        <media:title type="plain">Strategy compass</media:title>
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    <item>
      <title>Bio Korea 2026: US policy risks shift to execution framework</title>
      <description>
        <![CDATA[Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730835</guid>
      <pubDate>Mon, 04 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730835-bio-korea-2026-us-policy-risks-shift-to-execution-framework</link>
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        <media:title type="plain">Strategy compass</media:title>
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    <item>
      <title>First PROTAC: Arvinas’ Veppanu wins FDA nod in breast cancer</title>
      <description>
        <![CDATA[A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis targeting chimera, or PROTAC, drug to reach the market.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730770</guid>
      <pubDate>Fri, 01 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730770-first-protac-arvinas-veppanu-wins-fda-nod-in-breast-cancer</link>
    </item>
    <item>
      <title>Axsome’s Auvelity cleared for large Alzheimer’s agitation market</title>
      <description>
        <![CDATA[Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, a condition that affects up to three-quarters of patients, gaining access to a $1 billion-plus market and a clean label that counters the boxed warning of a competitor. The agency accepted the supplemental NDA under priority review on Dec. 31, 2025, and the breakthrough therapy approval, specifically for agitation associated with dementia due to Alzheimer’s disease, came on the April 30, 2026, PDUFA date.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730751</guid>
      <pubDate>Fri, 01 May 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730751-axsomes-auvelity-cleared-for-large-alzheimers-agitation-market</link>
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        <media:title type="plain">Auvelity </media:title>
        <media:description type="plain">Credit: Axsome Therapeutics Inc.</media:description>
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    <item>
      <title>Unique trial strategy muddies the ODAC waters for camizestrant </title>
      <description>
        <![CDATA[Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730745</guid>
      <pubDate>Thu, 30 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730745-unique-trial-strategy-muddies-the-odac-waters-for-camizestrant</link>
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        <media:title type="plain">Breast anatomy</media:title>
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    </item>
    <item>
      <title>Laguna Biotherapeutics’ LGNA-100 gains IND clearance</title>
      <description>
        <![CDATA[Laguna Biotherapeutics Inc. has obtained IND clearance from the FDA for its cancer immunotherapeutic LGNA-100 (QUAIL-100). The planned first-in-human phase I study will evaluate LGNA-100 in pediatric and young adult participants with high-risk acute leukemias and myelodysplastic syndromes following αβ-depleted hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730792</guid>
      <pubDate>Thu, 30 Apr 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730792-laguna-biotherapeutics-lgna-100-gains-ind-clearance</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cancer/Leukemia.webp?t=1588713330" type="image/png" medium="image" fileSize="421137">
        <media:title type="plain">Leukemia illustration</media:title>
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    </item>
    <item>
      <title>FDA looks toward a future of continuous real-time trials</title>
      <description>
        <![CDATA[Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730809</guid>
      <pubDate>Wed, 29 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730809-fda-looks-toward-a-future-of-continuous-real-time-trials</link>
    </item>
    <item>
      <title>Enterobiotix raises $25.7M for phase IIb of microbiome pill in IBS</title>
      <description>
        <![CDATA[Microbiome specialist Enterobiotix Ltd. has raised £19 million (US$25.7 million) to fund phase IIb development of its lead program EBX-102-02 in the treatment of irritable bowel syndrome with constipation (IBS-C).]]>
      </description>
      <guid>http://www.bioworld.com/articles/730688</guid>
      <pubDate>Wed, 29 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730688-enterobiotix-raises-257m-for-phase-iib-of-microbiome-pill-in-ibs</link>
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        <media:title type="plain">British pound symbol</media:title>
      </media:content>
    </item>
    <item>
      <title>Bio Korea 2026 kicks off with spotlight on oligonucleotides</title>
      <description>
        <![CDATA[Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730686</guid>
      <pubDate>Wed, 29 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730686-bio-korea-2026-kicks-off-with-spotlight-on-oligonucleotides</link>
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        <media:title type="plain">AI generated image for researcher developing antisense oligonucleotides</media:title>
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    </item>
    <item>
      <title>FDA proposes withdrawing Amgen’s Tavneos </title>
      <description>
        <![CDATA[Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730788</guid>
      <pubDate>Tue, 28 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730788-fda-proposes-withdrawing-amgens-tavneos</link>
    </item>
    <item>
      <title>Pilatus PLT-012 takes immunometabolic approach to reprogram TME </title>
      <description>
        <![CDATA[Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”]]>
      </description>
      <guid>http://www.bioworld.com/articles/730671</guid>
      <pubDate>Tue, 28 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730671-pilatus-plt-012-takes-immunometabolic-approach-to-reprogram-tme</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cancer/Monoclonal-antibody-cancer-tumor-illustration.webp?t=1765295036" type="image/jpeg" medium="image" fileSize="555950">
        <media:title type="plain">Illustration of monoclonal antibody treatment for cancer</media:title>
      </media:content>
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      <title>Taiho and Araris announce IND clearance for ARC-02</title>
      <description>
        <![CDATA[Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd. and Araris Biotech AG have announced completion by the FDA of the IND review period for ARC-02, enabling initiation of a phase I trial by Taiho Oncology.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730721</guid>
      <pubDate>Tue, 28 Apr 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730721-taiho-and-araris-announce-ind-clearance-for-arc-02</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cancer/Non-Hodgkin-lymphoma-cells-in-the-blood-flow.webp?t=1642718747" type="image/png" medium="image" fileSize="492874">
        <media:title type="plain">Non-Hodgkin lymphoma cells in the blood flow</media:title>
      </media:content>
    </item>
    <item>
      <title>Adcoms off to sluggish start with ODAC meeting on Astrazeneca drugs </title>
      <description>
        <![CDATA[After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 30 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic hormone-sensitive prostate cancer that’s phosphatase and tensin homolog deficient.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730669</guid>
      <pubDate>Tue, 28 Apr 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730669-adcoms-off-to-sluggish-start-with-odac-meeting-on-astrazeneca-drugs</link>
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        <media:title type="plain">Meeting illustration</media:title>
      </media:content>
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      <title>Grace Therapeutics hits CRL setback with GTx-104 despite positive trial  </title>
      <description>
        <![CDATA[Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730615</guid>
      <pubDate>Fri, 24 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730615-grace-therapeutics-hits-crl-setback-with-gtx-104-despite-positive-trial</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Neurology/Cerebral-aneurysm-illustration.webp?t=1777060629" type="image/jpeg" medium="image" fileSize="92490">
        <media:title type="plain">Cerebral aneurysm illustration</media:title>
      </media:content>
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      <title>Citizen petition asks for clarity in CRL disclosures  </title>
      <description>
        <![CDATA[The U.S. FDA’s recent pledge to make public complete response letters (CRLs) for drugs and biologics that failed to gain approval has encountered some objections from industry regarding the potential for disclosure of trade secrets and proprietary information.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730606</guid>
      <pubDate>Thu, 23 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730606-citizen-petition-asks-for-clarity-in-crl-disclosures</link>
    </item>
    <item>
      <title>A free gene therapy? Regeneron’s Otarmeni approved for hearing loss</title>
      <description>
        <![CDATA[Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals Inc.’s DB-OTO, an AAV-mediated gene therapy. Branded Otarmeni (lunsotogene parvec), it is cleared specifically for hearing loss caused by variants in the otoferlin gene.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730604</guid>
      <pubDate>Thu, 23 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730604-a-free-gene-therapy-regenerons-otarmeni-approved-for-hearing-loss</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/ENT/Boy-cupping-ear-with-soundwaves.webp?t=1776979575" type="image/jpeg" medium="image" fileSize="599085">
        <media:title type="plain">Boy cupping ear with soundwave graphic</media:title>
      </media:content>
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    <item>
      <title>FDA, CMS partner to deliver RAPIDly for innovative devices </title>
      <description>
        <![CDATA[The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730603</guid>
      <pubDate>Thu, 23 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730603-fda-cms-partner-to-deliver-rapidly-for-innovative-devices</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/thumb/CMS-logo-and-website.webp?t=1689968783" type="image/jpeg" medium="image" fileSize="62055">
        <media:title type="plain">CMS logo and website</media:title>
      </media:content>
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    <item>
      <title>Dupi whoopie: Sanofi/Regeneron cheered for sales, new approval</title>
      <description>
        <![CDATA[As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730601</guid>
      <pubDate>Thu, 23 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730601-dupi-whoopie-sanofi-regeneron-cheered-for-sales-new-approval</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Dupixent.webp?t=1674851490" type="image/png" medium="image" fileSize="132469">
        <media:title type="plain">Dupixent </media:title>
      </media:content>
    </item>
    <item>
      <title>FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC</title>
      <description>
        <![CDATA[The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730580</guid>
      <pubDate>Tue, 21 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730580-fda-grants-priority-review-to-merck-daiichis-b7-h3-cancer-adc</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cancer/lung-cancer.webp?t=1588881354" type="image/png" medium="image" fileSize="422296">
        <media:title type="plain">Lung cancer illustration</media:title>
      </media:content>
    </item>
    <item>
      <title>Merck wins US FDA nod for Idvynso, a two-drug HIV regimen </title>
      <description>
        <![CDATA[Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730488</guid>
      <pubDate>Tue, 21 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730488-merck-wins-us-fda-nod-for-idvynso-a-two-drug-hiv-regimen</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Idvynso-bottle.webp?t=1776806199" type="image/jpeg" medium="image" fileSize="132367">
        <media:title type="plain">Idvynso</media:title>
        <media:description type="plain">Credit: Merck &amp;amp; Co. Inc.</media:description>
      </media:content>
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    <item>
      <title>Targeted therapies dominate March’s five NME approvals</title>
      <description>
        <![CDATA[U.S. FDA drug approvals totaled 19 in March 2026, matching February and showing a solid level of regulatory activity, though slightly below the 22 approvals recorded in March 2025 and under the spike of 30 seen in March 2024.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730472</guid>
      <pubDate>Mon, 20 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730472-targeted-therapies-dominate-marchs-five-nme-approvals</link>
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        <media:title type="plain">FDA Approved seal</media:title>
      </media:content>
    </item>
    <item>
      <title>Psychedelic space expanding on Trump’s EO</title>
      <description>
        <![CDATA[Timothy Leary is dead, but he could be on the outside looking in with a smile on his face as U.S. President Donald Trump’s latest executive order (EO) fuels a surge in investment in companies researching and developing psychedelic drugs to treat mental health issues. The EO, Accelerating medical treatments for serious mental illness, is intended to address the increasing burden of suicide and serious mental illness, which impacts more than 14 million Americans.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730465</guid>
      <pubDate>Mon, 20 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730465-psychedelic-space-expanding-on-trumps-eo</link>
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        <media:title type="plain">Green arrow on blue abstract background</media:title>
      </media:content>
    </item>
    <item>
      <title>FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC</title>
      <description>
        <![CDATA[The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730392</guid>
      <pubDate>Thu, 16 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730392-fda-grants-priority-review-to-merck-daiichis-b7-h3-cancer-adc</link>
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        <media:title type="plain">Lung cancer illustration</media:title>
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    </item>
    <item>
      <title>FDA clears IND for Naturecell’s Astrostem-AU for autism</title>
      <description>
        <![CDATA[Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).]]>
      </description>
      <guid>http://www.bioworld.com/articles/730431</guid>
      <pubDate>Thu, 16 Apr 2026 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730431-fda-clears-ind-for-naturecells-astrostem-au-for-autism</link>
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        <media:title type="plain">Brain clay model</media:title>
      </media:content>
    </item>
    <item>
      <title>US FDA cites first dispenser for violating Rx supply chain act </title>
      <description>
        <![CDATA[If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products.]]>
      </description>
      <guid>http://www.bioworld.com/articles/730300</guid>
      <pubDate>Tue, 14 Apr 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/730300-us-fda-cites-first-dispenser-for-violating-rx-supply-chain-act</link>
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        <media:title type="plain">FDA sign</media:title>
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