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  • STAT+: Pharmalittle: We’re reading about a GSK deal for a drug from China, job losses in the U.S., and more
    GSK has continued its drive to bulk up its pipeline, taking global rights to a multiple myeloma treatment developed in China
    STAT · 1mo agoDealNeutral↗ source
  • NIH now allows businesses to apply for its research funding
    The National Institutes of Health announced that companies are eligible to submit grant applications, expanding the pool of potential research partners. This change aims to foster collaboration bet…
    STAT · 1mo agoRegulatoryPositive↗ source
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  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source
  • Experts urge FDA to require credentials for psychedelic therapy providers
    At a recent public hearing, mental health experts called on the FDA to adopt safety measures as it pushes to speed up psychedelic therapy development. The experts specifically recommended that pro…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 1mo agoRegulatoryNegative↗ source
  • Sionna Therapeutics to lay off 46% of staff after cystic fibrosis trial setback
    Sionna Therapeutics announced it will cut 46% of its workforce following an unexpected failure in its cystic fibrosis trial. The company, which employed about 59 people, said roughly 27 employees…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • HHS nominee Chris Klomp faces questioning from Sen. Elizabeth Warren on voluntary drug‑pricing contracts
    Deputy Secretary of Health and Human Services nominee Chris Klomp testified before the Senate Finance Committee on September 15, 2026. The hearing was described as relatively mild overall. During…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Rocket Pharmaceuticals aligns with FDA on Danon therapy as Novo exits Ascendis and Lilly announces new deal
    Rocket Pharmaceuticals said it has reached alignment with the U.S. FDA regarding its commercial-stage program for Danon disease, indicating the agency and the company are on the same page about the…
    Endpoints · 1mo agoNeutral↗ source
  • Omada Health posts first profitable quarter and prepares CEO succession
    Omada Health, a digital health company, completed its IPO a little over a year ago and has now posted its first profitable quarter, achieved in the spring. The profitability marks a milestone for…
    Endpoints · 1mo agoEarningsPositive↗ source
  • Kairon Health raises $5M to turn patient data into actionable to‑do lists for value‑based care practices
    Kairon Health, a health‑tech startup, offers a platform that aggregates patient information from claims, electronic health records and pharmacy data and converts it into actionable to‑do lists for…
    Endpoints · 1mo agoDealPositive↗ source
  • States urged to apply tobacco-settlement lessons to Meta’s $18 billion payout
    Susan Morrisey, former head of Colorado’s tobacco‑control coalition, reflects on how the 1998 tobacco settlement was debated and allocated among competing interests in the state. She recalls that…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RFK Jr. to keynote Children’s Health Defense event as hospitals criticize GOP rural health fund
    Robert F. Kennedy Jr. is slated to deliver the keynote address at a Children’s Health Defense gathering, marking a return to the anti-vaccine activism that defined his recent public profile. Hospi…
    STAT · 1mo agoNeutral↗ source
  • Danone USA recalls So Delicious Dairy Free Salted Caramel Cluster frozen dessert pints over possible foreign material
    Danone USA announced a voluntary recall of its So Delicious Dairy Free Salted Caramel Cluster non-dairy frozen dessert pints. The recall applies to pints with best‑by dates on or before April 3, 2…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • BioNTech's CTLA-4 antibody gotistobart shows 8.5-month survival boost in previously treated lung cancer patients
    BioNTech reported new data on its CTLA-4 targeting antibody gotistobart in lung cancer. The study focused on patients whose disease had progressed after prior therapy. Those receiving gotistobart…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Judge blocks Trump administration's plan to cap visas for grad students and postdocs
    A federal judge issued a preliminary injunction on Monday, stopping the Trump administration's plan to limit the length of visas used by graduate students and postdoctoral researchers. The Departm…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Abbott to pay $385 million to settle claims over 2022 baby-formula plant shutdown
    Abbott Laboratories agreed to a $385 million settlement related to the 2022 shutdown of its Sturgis, Michigan baby-formula plant, the largest in the United States. The plant’s problems triggered a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • A&P Creations recalls X10 supplement after discovering undeclared Viagra and Cialis ingredients
    A&P Creations LLC announced a voluntary recall of its X10 Natural Enhancement Supplement after testing revealed the presence of sildenafil and tadalafil, the active ingredients in prescription drug…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA seeks external input on rare disease trial criteria and endpoint selection
    The FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1mo agoNegative↗ source