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4,182 stories matching this filter · ← front page

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  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 1mo agoPositive readoutPositive↗ source
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  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Genentech CEO Ashley Magargee reflects on biotech origins and future amid growing startup ecosystem
    Genentech’s founder story was revisited in a recent interview with CEO Ashley Magargee. She recalled how co‑founder Herbert Boyer was initially skeptical of a brief meeting with venture capitalist…
    Fierce Biotech · 1mo agoPositive↗ source
  • ai3Bio raises $48 million to develop T-cell targeting therapy for autoimmune disease
    ai3Bio announced its emergence from stealth mode after securing $48 million in Series A funding. The round was led by UPMC Enterprises and Ziff Capital Partners and combines technology from Corner…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Merck licenses KRAS G12D inhibitor from Tao Hu for $400 million upfront
    Merck has signed a licensing agreement for a KRAS G12D inhibitor, providing an upfront payment of $400 million. The deal follows a 2023 transaction in which the same entrepreneur, synthetic chemis…
    Endpoints · 1mo agoDealNeutral↗ source
  • AbbVie’s once-daily Parkinson’s pill receives FDA approval
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for its once‑daily oral therapy for Parkinson’s disease. The decision allows the product to be marketed in the Unite…
    STAT · 1mo agoApprovalPositive↗ source
  • GLP-1 drugs shift from obesity treatment to lifestyle products, prompting setbacks for Merck and Daiichi
    The column notes that GLP-1 medicines, originally marketed to treat obesity as a medical condition, are now being promoted more as general lifestyle enhancers for appearance and wellbeing. Novo No…
    STAT · 1mo agoNegative↗ source
  • Roche halts obesity antibody emugrobart after negative phase 2 interim readout
    Roche has stopped development of its obesity antibody emugrobart after an interim analysis of a phase 2 trial indicated a low chance of meeting the study endpoints. The antibody, designed to block…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Mirum's Phase 3 Trial Shows Brelovitug Achieves Primary Endpoint in Hepatitis D Study
    Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial in chronic hepatitis delta met its primary efficacy goal, marking a significant step toward market entry in a field dominated by Gilead…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Kodiak Sciences' eye disease drug matches Eylea in Phase 3, sending stock soaring
    Kodiak Sciences reported that two of its eye‑disease candidates performed on par with aflibercept (Eylea) in a pivotal Phase 3 trial. The data suggest comparable efficacy in treating the targeted r…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI tools that aid vaccine design could also accelerate creation of bioweapons, warns former White House Covid adviser
    Ashish K. Jha, a former White House Covid‑19 response coordinator and senior fellow at Harvard Kennedy School, cautions that artificial intelligence is lowering the barriers that kept biological we…
    STAT · 1mo agoNegative↗ source
  • Merck signs $400 million deal with China’s SciBrunch for KRAS G12D preclinical candidate
    Merck & Co. announced a new partnership with Chinese biotech SciBrunch. The agreement includes a $400 million payment for a preclinical candidate that targets the KRAS G12D mutation. The KRAS G12D…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Sofinnova Partners raises €82 million to expand medtech creation strategy in Europe and U.S.
    Sofinnova Partners announced that it has secured €82 million ($93.3 million) in an oversubscribed financing round. The capital will be used to broaden the firm’s medtech creation strategy across Eu…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
    Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Adicet Bio reports early CAR-T therapy improves lupus symptoms, plans pivotal trial as shares fall
    Adicet Bio said its off-the-shelf CAR-T cell therapy showed signs of efficacy in a small early-stage trial involving patients with systemic lupus erythematosus. The study reported measurable impro…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Scynexis secures $200M+ BARDA contract for investigational antifungal SCY-247
    Scynexis announced a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) that provides more than $200 million to advance SCY-247, an experimental therapy aimed…
    Endpoints · 1mo agoDealPositive↗ source
  • Trump administration pulls nearly $1 billion from HHS programs for immigrants and diversity
    The White House announced a reversal of almost $1 billion in spending that Congress had previously approved for the Department of Health and Human Services. The reduction was made late on Friday ni…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer
    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Roche halts development of muscle-preserving obesity drug and returns program to Chugai
    Roche announced it is ending work on the experimental muscle-building compound known as GYM329, which had been tested together with a GLP-1 based anti-obesity injection. The decision stops the ong…
    Endpoints · 1mo agoNegative↗ source
  • Study finds toxic metal exposure persists months after Maui wildfires
    University of Hawai‘i researchers examined urine samples from about 1,400 adults as part of the Maui Wildfire Exposure Study, one of the nation’s largest investigations of post‑fire health effects.…
    STAT · 1mo agoNegative↗ source
  • Trump administration seeks Supreme Court stay on gender-affirming care restrictions in federal prisons
    The Trump administration filed an emergency petition with the Supreme Court asking it to pause a district judge’s order that requires continued provision of gender-affirming medical treatments to i…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Researchers identify previously unseen structure in the human heart
    An author of an opinion piece reports that a close visual inspection of the heart revealed a previously unrecognized anatomical structure. The discovery was made without new imaging technology, sim…
    STAT · 1mo agoPositive↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 1mo agoNegative↗ source
  • FDA greenlights AbbVie’s next-generation Parkinson’s drug tavapadon (Juvmo) with expected lower side effects
    The U.S. Food and Drug Administration has approved AbbVie’s new therapy for Parkinson's disease, tavapadon, which will be marketed under the name Juvmo. Tavapadon is a dopamine agonist intended to…
    Endpoints · 1mo agoApprovalPositive↗ source