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      <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.]]>
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      <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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      <title>AAD 2026: Targeted oral therapies challenge injected biologics</title>
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        <![CDATA[Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.]]>
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      <guid>http://www.bioworld.com/articles/729951</guid>
      <pubDate>Mon, 30 Mar 2026 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/729951-aad-2026-targeted-oral-therapies-challenge-injected-biologics</link>
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        <media:title type="plain">Oral medication</media:title>
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      <title>Apellis’ Empaveli approved in US for two rare kidney diseases</title>
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        <![CDATA[Following a priority review, Apellis Pharmaceuticals Inc. received U.S. FDA approval of a supplemental NDA making pegcetacoplan the second marketed treatment for complement 3 glomerulopathy and the first for primary immune complex membranoproliferative glomerulonephritis.]]>
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      <guid>http://www.bioworld.com/articles/722735</guid>
      <pubDate>Tue, 29 Jul 2025 15:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/722735-apellis-empaveli-approved-in-us-for-two-rare-kidney-diseases</link>
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        <media:title type="plain">Empaveli</media:title>
        <media:description type="plain">Credit: Apellis Pharmaceuticals Inc.</media:description>
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      <title>New chikungunya vaccine from Bavarian Nordic wins FDA nod</title>
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        <![CDATA[With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.]]>
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      <guid>http://www.bioworld.com/articles/717354</guid>
      <pubDate>Tue, 18 Feb 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/717354-new-chikungunya-vaccine-from-bavarian-nordic-wins-fda-nod</link>
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      <title>US FDA approves Pivya for uncomplicated UTIs </title>
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        <![CDATA[The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by <em>Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus</em>.]]>
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      <guid>http://www.bioworld.com/articles/707978</guid>
      <pubDate>Wed, 24 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707978-us-fda-approves-pivya-for-uncomplicated-utis</link>
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      <title>US FDA approves antibiotic Zevtera, Basilea seeks US partner</title>
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        <![CDATA[In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat <em>Staphylococcus aureus</em> bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.]]>
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      <guid>http://www.bioworld.com/articles/707281</guid>
      <pubDate>Thu, 04 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707281-us-fda-approves-antibiotic-zevtera-basilea-seeks-us-partner</link>
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        <media:title type="plain">Staphylococcus aureus</media:title>
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      <title>Mallinckrodt wins FDA nod for regenerative skin therapy for burns</title>
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        <![CDATA[More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. ]]>
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      <guid>http://www.bioworld.com/articles/508262</guid>
      <pubDate>Wed, 16 Jun 2021 01:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/508262-mallinckrodt-wins-fda-nod-for-regenerative-skin-therapy-for-burns</link>
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        <media:title type="plain">Stratagraft</media:title>
        <media:description type="plain">Stratagraft, which comprises human keratinocytes and dermal fibroblasts in an engineered, bilayer construct, is designed to mimic natural human skin. Credit: Mallinckrodt plc</media:description>
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