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3,276 stories matching this filter · ← front page

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  • Scientists release detailed basal ganglia cell map, uncover new neuron linked to schizophrenia
    Scientists from a large international collaboration have created the most detailed map of the basal ganglia, a brain region that coordinates movement and emotion. The effort profiled over 25 millio…
    STAT · 6h agoPositive↗ source
  • 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 · 7h agoNegative↗ source
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Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
fda recalls · 6h agoCRLNegative↗ source
  • Senate debate looms over Heidi Overton’s potential FDA nomination
    The article raises the question of whether Heidi Overton will be nominated to head the FDA and how the Senate might respond. It notes that a committee chair typically schedules a confirmation vote…
    STAT · 6h agoRegulatoryNeutral↗ 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 · 7h agoRegulatoryNegative↗ source
  • 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 · 8h agoRegulatoryNegative↗ 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 · 10h 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 · 11h agoNegative↗ 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 · 13h 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 · 14h 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 · 18h agoDealPositive↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 6h agoCRLNegative↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 6h 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 · 11h agoPositive readoutNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 11h agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 12h agoDealPositive↗ source
  • STAT+: Blackstone backs Pfizer’s bet on monthly obesity treatment
    Pfizer spent up to $10 billion to buy Metsera last year. Now, it’s bringing in private equity behemoth Blackstone to help pay for the deal.
    STAT · 6h agoRegulatoryNeutral↗ 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 · 13h agoNeutral↗ source
  • Kyverna pauses development of next-gen autoimmune CAR-T KYV-102 to focus on neurologic miv-cel program
    Kyverna Therapeutics announced it is halting work on its next-generation CD19 CAR-T candidate KYV-102, which had been positioned as a follow-up to its lead autoimmune CAR-T miv-cel. KYV-102 was de…
    Fierce Biotech · 13h agoNegative↗ source
  • ARPA-H bets $4.9 million on ibogaine for PTSD treatment in veterans
    The U.S. department of health and human services announced a $4.9 million bet to advance the development of ibogaine for post-traumatic stress disorder (PTSD).
    Fierce Biotech · 9h 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 · 13h 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 · 19h agoNeutral↗ source
  • Blackstone bets $1.5B on Pfizer’s obesity drug
    The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera.
    BioPharma Dive · 5h 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 · 10h 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