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  • Regeneron secures first FDA approval for gene therapy treating rare inherited hearing loss
    Regeneron announced that the U.S. Food and Drug Administration has approved its gene-based treatment Otarmeni, marking the first approval of a therapy for inherited hearing loss. The therapy is de…
    Endpoints · 4mo agoApprovalPositive↗ source
  • FDA approves Regeneron’s Otarmeni gene therapy for rare inherited hearing loss
    The FDA has approved Otarmeni, a gene therapy from Regeneron, marking the first therapy cleared under the agency’s national priority voucher program and will be provided to eligible patients at no…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
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  • AbbVie to invest $1.4 billion in new 185-acre manufacturing campus in Durham, North Carolina
    AbbVie announced a $1.4 billion investment to build a large manufacturing campus in Durham, North Carolina. The 185-acre site will focus on producing small-volume parenteral medicines such as vial…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sanofi beats Q1 sales forecasts, driven by strong Dupixent demand
    Sanofi reported first‑quarter results that exceeded Wall Street expectations, with net sales rising 6.2% to €10.5 billion (about $12.3 billion).\n\nThe growth was led by Dupixent, the anti‑inflamma…
    BioPharma Dive · 4mo agoEarningsPositive↗ source
  • Novo Nordisk's GLP-1 pill shows blood-sugar reduction in teens with type 2 diabetes
    Novo Nordisk reported results from a study evaluating its oral GLP-1 therapy, Rybelsus, in adolescents with type 2 diabetes. The trial enrolled participants aged 10-17 who took the pill for roughl…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Roche remains bullish on giredestrant despite first-line trial setback
    Roche's CEO Thomas Schinecker said the company still expects its investigational oral breast cancer therapy giredestrant to generate strong sales, potentially surpassing Herceptin. The optimism fo…
    Endpoints · 4mo agoNegative readoutNeutral↗ source
  • Trump touts completion of first round of White House drug pricing deals with Regeneron
    President Trump announced that a pricing agreement with Regeneron marks the final deal of an initial slate of 17 sought by the administration. Under the private arrangement, Regeneron will lower Me…
    STAT · 4mo agoDealNeutral↗ source
  • Trump administration allocates $50 million to psychedelic research and moves to downgrade medical marijuana
    President Trump signed an executive order that earmarks $50 million for research into psychedelics as potential mental‑health treatments and directs the FDA to accelerate their review process. The…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Novartis' Lutathera radioligand therapy may soon face first generic challenger
    Novartis has built a sizable business delivering radioligand therapies, with Lutathera being a leading product. A rival company is preparing to launch the first generic version, which could introd…
    Endpoints · 4mo agoNegative↗ source
  • Sanofi’s research focus may shift under new CEO Belén Garijo, amid gene therapy advances and telehealth debates
    Sanofi is entering a period of strategic reassessment as Belén Garijo assumes the chief executive role. Observers are watching to see whether the company will adjust its recent emphasis on immunolo…
    STAT · 4mo agoNeutral↗ source
  • Roche eyes up to $9 billion annual sales from breast cancer pill and obesity drug pipeline amid biosimilar pressure
    Roche reported first‑quarter earnings that showed a 5% dip in reported revenue, driven by a weaker U.S. dollar against the Swiss franc. On a constant‑currency basis, sales rose 6% to 14.7 billion S…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Amneal to acquire biosimilar maker for $375 million upfront
    Amneal Pharmaceuticals announced it will purchase a biosimilar development company, agreeing to pay $375 million in an upfront cash payment. The deal expands Amneal’s portfolio in the growing biosi…
    Endpoints · 4mo agoDealNeutral↗ source
  • CAR-T biotech Kelonia rebounds from cash crises to a $3 billion sale, while drugmakers explore Prescribery partnership
    The latest episode of STAT's "The Readout LOUD" podcast focuses on a dramatic turnaround at a CAR‑T biotech that faced near‑bankruptcy three times before being bought for more than $3 billion. The…
    STAT · 4mo agoPositive↗ source
  • Sanofi defends Garijo appointment and reaffirms commitment to immunology ahead of new CEO
    Sanofi held its first-quarter earnings call, with CFO François-Xavier Roger fielding questions from the media. During the call he defended the recent appointment of Belén Garijo, formerly of Merck…
    Endpoints · 4mo agoEarningsNeutral↗ source
  • Substance-use disorder biotech Tempero Bio shuts down after serious safety incident
    Tempero Bio, a biotech focused on treatments for substance use disorders, announced it will cease operations. The decision follows a serious adverse event that occurred during the company's develo…
    Endpoints · 4mo agoNegative↗ source
  • Opinion: Dropping the flu vaccine requirement puts U.S. military readiness at risk
    Since the 1918 pandemic, the military has acknowledged the threat of influenza. Now that’s changing.
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Endpoints News earns three Neal Awards for Trump coverage, CRISPR series and JPM event
    Endpoints News was honored with three Neal Awards in 2026. The awards recognize its reporting on the pharmaceutical industry's interactions with the Trump administration, a three-part series explo…
    Endpoints · 4mo agoPositive↗ source
  • Gravity Rail secures $2.75 million seed round to expand AI-driven patient communication platform
    Gravity Rail is a new company that builds artificial intelligence tools to help health care providers manage phone calls, text messages and follow‑up tasks with patients. The platform aims to strea…
    Endpoints · 4mo agoDealPositive↗ source
  • Mouse study links heart's constant beating to a hostile environment for cancer cells
    Heart disease and cancer are leading causes of death, yet tumors are rarely found in the heart, a fact clinicians have noted without clear explanation. Researchers reported in a Science paper that…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Trump nominates former deputy surgeon general Erica Schwartz as CDC director, testing MAHA influence
    President Trump has announced Erica Schwartz, a former deputy surgeon general, as the new CDC director. Schwartz is known for supporting vaccination and is seen as a traditional public‑health choic…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Colorado and Virginia lawmakers block attempts to limit drug affordability boards
    Legislators in Colorado and Virginia are pushing back against proposals to curb the authority of state prescription‑drug affordability boards. In Virginia, the General Assembly voted unanimously t…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Esther Wojcicki launches AI healthcare residency to aid startup co-founder collaboration
    Esther Wojcicki, often called the godmother of Silicon Valley, is turning her attention to health technology education. She is helping to launch a new AI healthcare residency program aimed at early…
    Endpoints · 4mo agoPositive↗ source
  • Amgen Announces Retirement of Chief Technology Officer David Reese
    Amgen announced that longtime leader David Reese will retire at the end of June. Reese, 63, currently serves as the company's chief technology officer, a position he created in 2023 after many yea…
    Endpoints · 4mo agoNeutral↗ source
  • Revolution Medicines' early-stage pancreatic cancer drug shows tumor control in half of patients
    Revolution Medicines reported that its experimental therapy daraxonrasib helped control tumors in at least half of patients with early-stage pancreatic cancer, whether given alone or with chemother…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Moderna launches Phase 3 trial of mRNA bird flu vaccine after US funding cut
    Moderna has begun enrolling participants in a Phase 3 trial of its mRNA-1018 vaccine targeting H5 influenza (bird flu). The trial aims to include about 4,000 healthy adults in the United States and…
    BioPharma Dive · 4mo agoPositive↗ source