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  • Bristol Myers unveils data for one of its next-gen blood cancer drugs
    Called mezigdomide, the drug is one of two protein-degrading medicines Bristol Myers hopes to soon position as successors to its lucrative Revlimid franchise.
    BioPharma Dive · 2mo ago↗ source
  • STAT+: Trump administration seeks to overhaul federal grantmaking process, alarming researchers
    The Trump administration has released a sweeping proposal to overhaul the bedrock regulation for all federal grants.
    STAT · 2mo ago↗ source
  • Next FDA user fee deal is under review at the White House
    The White House is examining a deal recently reached by the FDA and the biopharma industry that sets the prescription drug user fees that the sector will pay the agency from 2028 through 2032, sour…
    Endpoints
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fda recalls22
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Endocrinology & Metabolism290
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Nephrology239
· 2mo ago
↗ source
  • Post-Hoc: Lilly gets more secretive and hides Phase 1 pipeline
    Eli Lilly is getting more opaque as it gets bigger. Earlier this year, the drugmaker stopped disclosing its early-stage pipeline work. Its Phase 1 projects vanished from the company’s earnings pres…
    Endpoints · 2mo ago↗ source
  • Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
    A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.
    BioPharma Dive · 2mo ago↗ source
  • AstraZeneca seeks path for failed antibody; Imfinzi, Tremfya get label expansions
    🔎 AstraZeneca narrows path for failed antibody: The company announced last summer that its monoclonal antibody anselamimab missed the primary endpoint in a pair of Phase 3 trials for patients with…
    Endpoints · 2mo ago↗ source
  • Replimune will again submit its melanoma drug for approval
    Third time’s the charm? Replimune announced Friday that it will submit its advanced melanoma drug RP1 for FDA review after two prior rejections. It said it has had new discussions with ...
    Endpoints · 2mo ago↗ source
  • Kenya court suspends U.S. plan for Ebola quarantine facility for Americans
    A court in Kenya on Friday suspended a U.S. plan to establish a quarantine facility for Americans exposed to a rare type of Ebola virus spreading in northeastern Congo.
    STAT · 2mo ago↗ source
  • Agios ends development of tebapivat in low-risk MDS following subpar results
    Agios Pharmaceuticals has said it will stop developing its rare blood disorder drug for certain patients with myelodysplastic syndromes (MDS) due to disappointing Phase 2b data. The biotech’s pyruv…
    Endpoints · 2mo ago↗ source
  • Allogene CEO to step down; Agios drug fails key test
    David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.
    BioPharma Dive · 2mo ago↗ source
  • Can a chaotic FDA still deliver on faster drug development?
    As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.
    BioPharma Dive · 2mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more
    Pharma updates from the Pharmalot campus via the Pharmalittle newsletter
    STAT · 2mo ago↗ source
  • STAT+: Allogene CEO David Chang stepping down
    Pfizer invests billions to buy Chinese drugs, WHO maps experimental response to Ebola outbreak, and other biotech news from The Readout
    STAT · 2mo ago↗ source
  • STAT+: Massachusetts sues UnitedHealth, alleging fraud in state’s Medicaid plans for seniors
    State AG alleges UnitedHealthcare claimed some members were sicker to boost its profits.
    STAT · 2mo ago↗ source
  • Which vaccines will curb the Ebola outbreak? WHO debates
    The growing Ebola outbreak, the unknowns of microdosing GLP-1s, and more health news from Morning Rounds
    STAT · 2mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 2mo ago↗ source
  • #ASCO26: Bristol Myers details Phase 3 trial win for Pomalyst successor
    Bristol Myers Squibb’s next-gen multiple myeloma drug cut the risk of disease progression or death for certain patients by 52% when added on top of a combination treatment regimen. The New Jersey p…
    Endpoints · 2mo ago↗ source
  • Pfizer, Innovent strike $10B cancer drug deal
    Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.
    BioPharma Dive · 2mo ago↗ source
  • David Chang to hand over the reins at Allogene; Ex-Esperion CEO gets started at Phlow
    Longtime Allogene CEO David Chang will be stepping down at the end of June. Chang has served as the company’s CEO for the past eight years and will be succeeded by ...
    Endpoints · 2mo ago↗ source
  • Pfizer strikes Innovent deal worth up to $10.5B for a dozen cancer programs
    On the eve of this year’s ASCO annual meeting, Pfizer said it is teaming up with China’s Innovent Biologics to advance a portfolio of 12 early-stage antibody-drug conjugates and multi-specific anti…
    Endpoints · 2mo ago↗ source
  • STAT+: The woman behind the world’s biggest longevity competition
    Jamie Justice of XPRIZE Healthspan on the most promising research and "purely scammy" treatments in the world of longevity.
    STAT · 2mo ago↗ source
  • Opinion: I’m a weight-loss doctor. Here’s why I worry about GLP-1 ‘microdoses’
    Long term, we don’t know what tiny doses of GLP-1s for cosmetic weight loss can do, writes a weight-loss doctor.
    STAT · 2mo ago↗ source
  • STAT+: As Ebola outbreak in Central Africa grows, the U.S. turns itself into a fortress
    The U.S. is taking extraordinary steps to keep Ebola out. But its policies may create risks for Americans infected overseas and discourage volunteers from responding to the outbreak.
    STAT · 2mo ago↗ source
  • Lilly obesity meds Foundayo and Zepbound to gain CVS coverage
    Eli Lilly’s flagship obesity medications will be included in CVS Caremark formularies, likely boosting sales in the most competitive commercial drug market. The company announced Thursday that its…
    Endpoints · 2mo ago↗ source
  • GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’
    The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
    BioPharma Dive · 2mo ago↗ source