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    <title>Fast track</title>
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      <title>Lexicon rebounds on FDA nod for phase III non-opioid pain drug trial</title>
      <description>
        <![CDATA[Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728161</guid>
      <pubDate>Thu, 22 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728161-lexicon-rebounds-on-fda-nod-for-phase-iii-non-opioid-pain-drug-trial</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Neurology/Foot-pain-illustration.webp?t=1769118266" type="image/jpeg" medium="image" fileSize="330300">
        <media:title type="plain">Foot pain illustration</media:title>
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    <item>
      <title>Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets</title>
      <description>
        <![CDATA[Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725329</guid>
      <pubDate>Wed, 22 Oct 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725329-innovent-rings-up-114b-deal-with-takeda-for-three-i-o-adc-assets</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Cancer/Antibodies-attacking-cancer-cell.webp?t=1621365766" type="image/png" medium="image" fileSize="566115">
        <media:title type="plain">Antibodies attacking cancer cell</media:title>
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      <title>FDA green lights Cochlear’s smart cochlear implant</title>
      <description>
        <![CDATA[Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system.&nbsp;Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told <em>BioWorld</em>.]]>
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      <guid>http://www.bioworld.com/articles/721825</guid>
      <pubDate>Fri, 11 Jul 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/721825-fda-green-lights-cochlears-smart-cochlear-implant</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2025/Cochlear-Nuclea-Nexa-system-11july25.webp?t=1752265616" type="image/jpeg" medium="image" fileSize="154072">
        <media:title type="plain">Cochlear Nuclea Nexa system</media:title>
        <media:description type="plain">Cochlear Nuclea Nexa system. Credit: Cochlear Ltd.</media:description>
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      <title>CSPC hints at three upcoming deals worth $5B for EGFR ADC, others</title>
      <description>
        <![CDATA[CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.]]>
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      <guid>http://www.bioworld.com/articles/720905</guid>
      <pubDate>Tue, 03 Jun 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720905-cspc-hints-at-three-upcoming-deals-worth-5b-for-egfr-adc-others</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/CSPC-cropped-5-30.webp?t=1748634407" type="image/jpeg" medium="image" fileSize="581006">
        <media:title type="plain">CSPC headquarters</media:title>
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      <title>CSPC hints at three upcoming deals worth $5B for EGFR ADC, others</title>
      <description>
        <![CDATA[CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.]]>
      </description>
      <guid>http://www.bioworld.com/articles/720606</guid>
      <pubDate>Fri, 30 May 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720606-cspc-hints-at-three-upcoming-deals-worth-5b-for-egfr-adc-others</link>
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        <media:title type="plain">CSPC headquarters</media:title>
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    <item>
      <title>Healios posts more upbeat data on Multistem cell therapy for ARDS</title>
      <description>
        <![CDATA[Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.]]>
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      <guid>http://www.bioworld.com/articles/718438</guid>
      <pubDate>Tue, 18 Mar 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718438-healios-posts-more-upbeat-data-on-multistem-cell-therapy-for-ards</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Infectious/covid-19---coronavirus---lungs.webp?t=1745261044" type="image/jpeg" medium="image" fileSize="266577">
        <media:title type="plain">Coronavirus, lungs</media:title>
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    <item>
      <title>Healios posts more upbeat data on Multistem cell therapy for ARDS</title>
      <description>
        <![CDATA[Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718250</guid>
      <pubDate>Fri, 14 Mar 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718250-healios-posts-more-upbeat-data-on-multistem-cell-therapy-for-ards</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Infectious/covid-19---coronavirus---lungs.webp?t=1745261044" type="image/jpeg" medium="image" fileSize="266577">
        <media:title type="plain">Coronavirus, lungs</media:title>
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    <item>
      <title>US FDA grants fast track to Moebius-Sun’s knee OA pain injection</title>
      <description>
        <![CDATA[The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.]]>
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      <guid>http://www.bioworld.com/articles/712399</guid>
      <pubDate>Tue, 10 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712399-us-fda-grants-fast-track-to-moebius-suns-knee-oa-pain-injection</link>
    </item>
    <item>
      <title>US FDA grants fast track to Moebius-Sun’s knee OA pain injection</title>
      <description>
        <![CDATA[The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712355</guid>
      <pubDate>Mon, 09 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712355-us-fda-grants-fast-track-to-moebius-suns-knee-oa-pain-injection</link>
    </item>
    <item>
      <title>Mabwell joins ADC breast cancer race as China clears phase II</title>
      <description>
        <![CDATA[Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710609</guid>
      <pubDate>Tue, 16 Jul 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710609-mabwell-joins-adc-breast-cancer-race-as-china-clears-phase-ii</link>
    </item>
    <item>
      <title>SN Bioscience nabs FDA fast track for lung cancer drug </title>
      <description>
        <![CDATA[SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer. ]]>
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      <guid>http://www.bioworld.com/articles/708605</guid>
      <pubDate>Tue, 14 May 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/708605-sn-bioscience-nabs-fda-fast-track-for-lung-cancer-drug</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2024/SN-Bioscience-5-10.webp?t=1715373171" type="image/jpeg" medium="image" fileSize="193457">
        <media:title type="plain">Vials of SNB-101</media:title>
        <media:description type="plain">Credit: SN Bioscience</media:description>
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    <item>
      <title>SN Bioscience nabs FDA fast track for lung cancer drug </title>
      <description>
        <![CDATA[SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer. ]]>
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      <guid>http://www.bioworld.com/articles/708476</guid>
      <pubDate>Fri, 10 May 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/708476-sn-bioscience-nabs-fda-fast-track-for-lung-cancer-drug</link>
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        <media:title type="plain">Vials of SNB-101</media:title>
        <media:description type="plain">Credit: SN Bioscience</media:description>
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      <title>Ahead of IPO, D&amp;D Pharmatech wins US fast track for MASH drug</title>
      <description>
        <![CDATA[Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707387</guid>
      <pubDate>Tue, 09 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707387-ahead-of-ipo-d-and-d-pharmatech-wins-us-fast-track-for-mash-drug</link>
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    <item>
      <title>US FDA approves antibiotic Zevtera, Basilea seeks US partner</title>
      <description>
        <![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.]]>
      </description>
      <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>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/Infectious/Staphylococcus-aureus-staph-bacteria-infection.webp?t=1745260787" type="image/jpeg" medium="image" fileSize="394886">
        <media:title type="plain">Staphylococcus aureus</media:title>
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    <item>
      <title>Ahead of IPO, D&amp;D Pharmatech wins US fast track for MASH drug</title>
      <description>
        <![CDATA[Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707275</guid>
      <pubDate>Thu, 04 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707275-ahead-of-ipo-d-and-d-pharmatech-wins-us-fast-track-for-mash-drug</link>
    </item>
    <item>
      <title>Plus Therapeutics’ Rhenium Nanoliposomes are fast tracked in glioblastoma</title>
      <description>
        <![CDATA[The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.]]>
      </description>
      <guid>http://www.bioworld.com/articles/497799</guid>
      <pubDate>Tue, 15 Sep 2020 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/497799-plus-therapeutics-rhenium-nanoliposomes-are-fast-tracked-in-glioblastoma</link>
    </item>
    <item>
      <title>Viiv wins FDA approval for new late-line HIV drug</title>
      <description>
        <![CDATA[Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.]]>
      </description>
      <guid>http://www.bioworld.com/articles/436243</guid>
      <pubDate>Mon, 06 Jul 2020 13:30:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/436243-viiv-wins-fda-approval-for-new-late-line-hiv-drug</link>
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        <media:title type="plain">FDA Approved seal</media:title>
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    </item>
    <item>
      <title>FDA grants fast track designation to Carmell Therapeutics bone healing accelerant</title>
      <description>
        <![CDATA[Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.]]>
      </description>
      <guid>http://www.bioworld.com/articles/434774</guid>
      <pubDate>Thu, 30 Apr 2020 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/434774-fda-grants-fast-track-designation-to-carmell-therapeutics-bone-healing-accelerant</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2020/4-29-Carmell-bone-healing-accelerant.webp?t=1588198723" type="image/png" medium="image" fileSize="1584164">
        <media:title type="plain">4-29-Carmell-bone-healing-accelerant.png</media:title>
        <media:description type="plain">Bone healing accelerant putty. Credit: Carmell Therapeutics Corp.</media:description>
      </media:content>
    </item>
    <item>
      <title>FDA grants fast track designation to Carmell Therapeutics bone healing accelerant</title>
      <description>
        <![CDATA[Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.]]>
      </description>
      <guid>http://www.bioworld.com/articles/434752</guid>
      <pubDate>Wed, 29 Apr 2020 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/434752-fda-grants-fast-track-designation-to-carmell-therapeutics-bone-healing-accelerant</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2020/4-29-Carmell-bone-healing-accelerant.webp?t=1588198723" type="image/png" medium="image" fileSize="1584164">
        <media:title type="plain">4-29-Carmell-bone-healing-accelerant.png</media:title>
        <media:description type="plain">Bone healing accelerant putty. Credit: Carmell Therapeutics Corp.</media:description>
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