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2,463 stories matching this filter · ← front page

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  • Trump's MFN drug pricing agreements complicate new drug launches
    President Donald Trump announced nine new agreements with drug manufacturers on Aug. 31, extending the “most favored nation” (MFN) pricing framework. Under MFN, U.S. prices for participating drugs…
    Endpoints · 14h agoRegulatoryNegative↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 14h agoRegulatoryNeutral↗ source
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  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 16h agoPositive readoutNeutral↗ source
  • Heron sells assets to CorMedix for $145M upfront, Faeth shares plunge
    Heron Therapeutics announced it has sold a portfolio of assets to CorMedix for an upfront cash payment of $145 million. The transaction gives CorMedix additional product candidates and expands its…
    Endpoints · 18h agoDealNeutral↗ source
  • Zura Bio’s Phase 2 trial of tibulizumab fails, shares plunge
    Zura Bio announced that its experimental drug tibulizumab did not meet efficacy endpoints in a Phase 2 study of a painful skin disorder. The company said that both dose levels performed no better t…
    Endpoints · 21h agoNegative readoutNegative↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 1d agoNeutral↗ source
  • FDA reduces required analytical tests for emergency-use diagnostic devices
    The FDA finalized new guidance aimed at streamlining validation for in-vitro diagnostic (IVD) devices that detect emerging pathogens during public-health emergencies. The guidance lowers the numbe…
    raps · 1d agoRegulatoryNeutral↗ source
  • Pentagon removes WuXi AppTec from Chinese military companies list, but risk of redesignation remains
    The U.S. Department of Defense announced that WuXi AppTec, a Shanghai-based contract research and manufacturing firm, has been taken off the Pentagon’s list of Chinese entities tied to the People’s…
    Endpoints · 15h agoRegulatoryNeutral↗ source
  • Cardinal Health updates use instructions for Presource kits with BD Alaris infusion sets
    Cardinal Health has sent a letter to customers updating the use instructions for its Presource convenience kits that contain BD Alaris pump infusion sets. The update does not call for removal of t…
    fda medwatch · 1d agoCRLNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 20h agoLayoffsNegative↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 20h ago↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Vir Biotechnology reports positive results for hepatitis D combo in first pivotal trial
    Vir Biotechnology announced that its chronic hepatitis D treatment met its primary goal in the first of three late‑stage studies. The trial evaluated a once‑monthly combination therapy that include…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • Novo and Novartis see heart drug setbacks as trials show minimal efficacy
    Novo's cardiovascular candidate failed to demonstrate meaningful benefit in its pivotal study, causing the company's shares to fall about 9% in July. The trial data showed the drug had little effe…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Democrats Take House, Raising Questions for Biopharma Policy
    Democrats secured control of Congress in a wave election held on Tuesday, shifting the political balance in Washington. The change is expected to influence the regulatory landscape for the biophar…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Harvard scientist George Church quits AI startup Radical, alleging partner stole his credit
    George Church, a prominent Harvard researcher known for advising biotech and synthetic biology ventures, has stepped down from his role at the artificial‑intelligence startup Radical. In a public…
    Endpoints · 3d agoNegative↗ source
  • FDA probes cancer risk from Zolgensma gene therapy after post-marketing tumor reports
    The FDA has issued a safety communication indicating it is investigating reports of malignancies in patients treated with Zolgensma, the adeno‑associated virus gene therapy for spinal muscular atro…
    fda medwatch · 4d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 3d agoApprovalPositive↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 3d agoEarningsPositive↗ source
  • Amgen's Repatha shows reduced heart attack risk while Satellos alters Duchenne trial endpoint
    Satellos Bioscience announced a change to the primary endpoint of its ongoing Duchenne muscular dystrophy trial of the investigational small‑molecule forazapadin, shifting focus to a measure of mus…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Forge Biologics VP sees AI and Ohio talent driving next wave of gene therapy manufacturing
    Samantha Piteri-Molina, vice president of business and strategy at Forge Biologics, said her focus is on getting gene therapies into patients' hands. She helped steer Forge through a $620 million…
    BioSpace · 3d agoPositive↗ source
  • Agios cuts over 35% of R&D staff as FDA decision on sickle cell drug is delayed
    Agios announced it will eliminate more than 100 R&D positions, representing over a third of its research staff, after the FDA postponed a decision on its sickle cell disease candidate. The company…
    BioSpace · 3d agoLayoffsNegative↗ source