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2,137 stories matching this filter · ← front page

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  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 17d agoCRLPositive↗ source
  • FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis
    On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand na…
    STAT · 16d agoApprovalPositive↗ source
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Infectious Disease457
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 16d agoRegulatoryPositive↗ source
  • Hospitals Prepare Lobbying Effort to Counter $1 Trillion Health Care Funding Cuts
    Hospitals are gearing up to lobby Congress after a projected $1 trillion reduction in health‑care spending, which was part of recent tax‑cut legislation. Hospital leaders say they will seek higher…
    STAT · 16d agoRegulatoryNegative↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 16d agoRegulatoryNeutral↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 17d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 17d agoDealPositive↗ source
  • Proposed Biotech Investment National Security Act may protect US firms but contains loophole aiding Chinese competition
    A bipartisan bill called the Biotech Investment National Security Act (BINSA) has been introduced in Congress to expand federal oversight of biotechnology activities, from drug development to biolo…
    STAT · 17d agoRegulatoryNegative↗ source
  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 17d agoNegative↗ source
  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 17d agoNeutral↗ source
  • DEA moves on kratom substances as FDA greenlights new pancreatic drug
    The Drug Enforcement Administration is taking new steps concerning substances associated with kratom, signaling a shift in how the agency handles the plant-derived compounds. In a separate develop…
    STAT · 17d agoRegulatoryNeutral↗ source
  • CMS to host launch event for ACCESS, its new Medicare chronic care pilot
    CMS announced it will hold a launch event for ACCESS, a pilot program aimed at chronic care management for Medicare beneficiaries. The pilot is intended to test new care coordination models and pa…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Ana Salazar Modela Tu Cuerpo recalls Lipofit Extreme Fat Burner 2.0 after FDA finds undeclared fluoxetine and DNP
    Ana Salazar Modela Tu Cuerpo Inc. announced a voluntary nationwide recall of its Lipofit Extreme Fat Burner 2.0 on August 27, 2026, targeting the lot with expiration in September 2027. FDA laborat…
    fda recalls · 17d agoCRLNegative↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 17d agoNeutral↗ source
  • Louisiana directs 20% of opioid settlement funds to sheriffs, who spend millions on police equipment
    KFF Health News investigated how Louisiana sheriffs used their share of opioid settlement money. The state allocated 20% of the settlement payouts to the 64 elected sheriffs, the largest law‑enfor…
    STAT · 17d agoNegative↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 17d agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 17d agoNeutral↗ source
  • Former Stanford president posts emails to counter fraud claims in new book
    Former Stanford president Marc Tessier-Lavigne has posted a more than 3,000-word response on his lab website, including emails with former colleagues, to dispute claims that he fabricated research…
    STAT · 16d agoNegative↗ source
  • Documents show RFK Jr. sought to study Samoa’s MMR vaccines despite claiming his 2019 visit was unrelated to vaccines
    Health secretary Robert F. Kennedy Jr. told lawmakers that his 2019 trip to Samoa had nothing to do with vaccines. New documents obtained by the Associated Press and The Guardian include a letter…
    STAT · 17d agoRegulatoryNegative↗ source
  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 18d agoApprovalPositive↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 17d agoApprovalPositive↗ source
  • FDA approves Rasonque, first therapy targeting genetic cause of advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval to Rasonque, a drug from Revolution Medicines, for patients with advanced pancreatic cancer. The medicine, whose generic name is daraxonra…
    STAT · 17d agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 18d agoApprovalPositive↗ source
  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 18d agoPositive readoutPositive↗ source