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  • Regeneron and Sanofi explore expanded partnership for Dupixent follow-on candidates
    Regeneron and Sanofi said they are in early discussions about expanding their collaboration beyond the existing Dupixent partnership. The companies indicated the potential scope could include deve…
    Endpoints · 14h agoDealPositive↗ source
  • Replimune argues its oncolytic virus plus checkpoint inhibitor benefits advanced melanoma patients at FDA advisory meeting
    Replimune presented data from its pivotal advanced melanoma trial to an FDA advisory committee. The company defended the trial design and results, emphasizing the added benefit of its oncolytic vi…
    Endpoints · 14h agoRegulatoryNeutral↗ source
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  • Senate health panel confirms Trump picks for CDC director and pandemic preparedness chief
    The Senate health committee approved two Trump administration nominees for key health positions on Thursday. Erica Schwartz was confirmed as CDC director with bipartisan support from all Republica…
    STAT · 19h agoRegulatoryNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Podcast debates FDA’s handling of Duchenne drugs and upcoming executive changes
    Allison DeAngelis, Adam Feuerstein and Elaine Chen host this week’s Readout Loud podcast, a STAT series that examines biotech trends and business moves. The trio questions whether the FDA is apply…
    STAT · 14h agoNeutral↗ source
  • Takeda, Regeneron, Sanofi and Bristol Myers Squibb announce pipeline cuts in quarterly updates
    Takeda, Regeneron, Sanofi and Bristol Myers Squibb disclosed that they are trimming several drug development programs as part of their recent earnings releases. The cuts affect a mix of early‑stage…
    Endpoints · 18h agoNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 1d agoNegative↗ source
  • Gerresheimer sells Centor and Primary Packaging Plastics units to Apax Partners for €1.5 billion
    Gerresheimer announced it is divesting two of its businesses, the Centor unit and the Primary Packaging Plastics (PPP) unit, to private‑equity firm Apax Partners. The transaction is valued at rough…
    Endpoints · 20h agoDealNeutral↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 1d agoRegulatoryNegative↗ source
  • Federal judge rejects 26 states' bid to delay Medicaid work requirement rollout
    A U.S. District Judge in Massachusetts issued an order Thursday refusing to grant a preliminary injunction that would have paused the new Medicaid work‑requirement rules. The decision leaves the fe…
    STAT · 20h agoRegulatoryNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 1d agoNegative↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 1d agoRegulatoryNegative↗ source
  • Trump's CDC nominee Erica Schwartz clears key Senate committee vote
    Erica Schwartz, a former deputy surgeon general, was nominated by the Trump administration to lead the CDC. On July 15, 2026 she testified before the Senate Health, Education, Labor and Pensions C…
    Endpoints · 18h agoRegulatoryNeutral↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 1d agoEarningsPositive↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1d agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1d agoNegative readoutNegative↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 1d agoPositive readoutPositive↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 1d agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 1d agoRegulatoryNegative↗ source