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  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 1h agoNegative↗ source
  • New documents spark fresh concerns over Medicare's AI prior-authorization pilot
    New documents have been released that raise additional questions about Medicare's experiment using artificial intelligence to handle prior-authorization requests. The pilot, which seeks to automat…
    STAT · 1h agoRegulatoryNegative↗ source
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  • FDA shelves fast-track drug review program launched in 2025
    The U.S. Food and Drug Administration announced it is suspending the fast-track drug review initiative that was introduced in June 2025 under former commissioner Marty Makary. The program, called…
    STAT · 1h agoRegulatoryNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 2h agoNegative↗ source
  • American Cancer Society recommends routine PSA screening for men 50-69, strengthens guidance for high-risk groups
    The American Cancer Society (ACS) has updated its prostate-cancer screening guidelines, now advising men at average risk aged 50 to 69 to have a PSA blood test every two years. This replaces the 20…
    STAT · 4h agoRegulatoryPositive↗ source
  • Alnylam faces slowdown in Amvuttra sales, putting its growth ambitions at risk
    Alnylam’s market narrative has long hinged on the performance of its cardiomyopathy drug Amvuttra. The company once hoped the therapy could lift its valuation toward the $100 billion range. Recent…
    STAT · 4h agoNegative↗ source
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 4h agoDealPositive↗ source
  • New governors should prioritize health hires, vaccination data, and a focused agenda
    Mandy Cohen and Ellen Montz, former state health leaders, write an opinion piece aimed at the 21 governors who will assume office on Jan. 1. They draw on their experience at the CDC, state health d…
    STAT · 6h agoPositive↗ source
  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 7h agoNeutral↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 12h agoDealPositive↗ source
  • Bristol Myers shifts R&D leadership to chief medical officer Cristian Massacesi as research head Robert Plenge departs
    Bristol Myers Squibb announced a reorganization of its research and development structure. The company said chief medical officer and head of development Cristian Massacesi will assume the duties…
    Endpoints · 3h agoNeutral↗ source
  • Biogen prepares to unveil results of litifilimab Phase 3 TOPAZ-1 and TOPAZ-2 lupus trials in December
    Biogen is set to release the readout from two pivotal Phase 3 studies, TOPAZ-1 and TOPAZ-2, evaluating its lupus drug litifilimab. The data are expected in the first half of December and will be th…
    STAT · 4h agoPositive readoutNeutral↗ source
  • Newly elected doctors and scientists aim to rebuild public trust in science after midterm wins
    Last week doctors and scientists across the United States were elected to office, with the help of the group 314 Action. The organization, which supports Democratic candidates with scientific backg…
    STAT · 6h agoNeutral↗ source
  • Study finds Black Americans share many concerns with MAHA despite low overall support
    Jerel Ezell, an epidemiologist at the University of Chicago Medical Center, writes an opinion piece examining the complex relationship between the MAHA movement and Black Americans. A 2025 poll by…
    STAT · 6h agoNeutral↗ source
  • Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch
    Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist.
    Fierce Biotech · 12h agoNeutral↗ source
  • STAT+: Will Heidi Overton get to run the FDA?
    Does Heidi Overton have the votes ? And how will Dems take on RFK Jr.?
    STAT · 23m ago↗ source
  • Merck KGaA's writedown over Lonza deal; PharmaLogic buys Lantheus' CDMO business
    Merck KGaA’s impairment hit from CDMO sale: The German conglomerate reported a €366 million ($405.8 million) impairment loss on its business sale to Lonza, according to its third-quarter earnings r…
    Endpoints · 55m ago↗ source
  • Experts update prostate cancer screening guidelines for men
    Are you an American man between 50 and 69? You might want to get checked for prostate cancer, ACS says in reversal of previous guidelines.
    STAT · 3h ago↗ source
  • Vor pays RemeGen $10M for long-acting addition to autoimmune pipeline
    Vor Bio is paying RemeGen $10 million upfront in cash for rights to RC298 outside Greater China, adding a long-acting drug candidate to its BAFF/APRIL franchise.
    Fierce Biotech · 5h ago↗ source
  • Kyverna abandons next-gen autoimmune CAR-T once touted as follow-up to miv-cel
    Kyverna is halting work on a next-gen CD19 CAR-T therapy as the biotech seeks FDA approval for what could become the first CAR-T treatment for an autoimmune disease.
    Fierce Biotech · 6h ago↗ source
  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Study of 100,000 diverse Americans uncovers thousands of new drug-response genetic variants
    A new analysis of data from the NIH All of Us program examined nearly 100,000 participants from a wide range of ancestries. Researchers identified thousands of previously unknown genetic variants i…
    STAT · 18h agoPositive↗ source
  • U.S. 'most-favored nations' policy prompts drugmakers to reconsider overseas launches
    The White House's "most-favored nations" rule, which would tie foreign drug prices to U.S. prices, is causing U.S. pharma firms to rethink launching products abroad. Companies are exploring strate…
    STAT · 20h agoRegulatoryNeutral↗ source
  • Senate Health Committee Schedules Vote on FDA Commissioner Nominee Heidi Overton
    Senate health committee set a vote for November 18 on President Trump's nominee Heidi Overton to become FDA commissioner. The outcome will determine whether the nomination proceeds to the full Sen…
    STAT · 1d agoRegulatoryNeutral↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 1d agoDealPositive↗ source