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1,982 stories matching this filter · ← front page

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  • Novartis and Novo Nordisk see back-to-back cardiovascular trial failures, raising doubts for the field
    Novartis announced that its experimental heart‑protective therapy, pelacarsen, did not meet its primary endpoints in a seven‑year study designed to cut heart attacks and strokes by lowering lipopro…
    STAT · 6h agoNegative readoutNegative↗ source
  • Cancer drug shortages persist, hampering patient care and highlighting lasting impacts of platinum chemotherapy
    The STAT+ newsletter reports that cancer treatment centers continue to struggle with ongoing shortages of key oncology drugs, forcing clinicians to alter or delay therapy for patients. These short…
    STAT · 1h agoNegative↗ source
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fda recalls71
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  • FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGs
    The U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…
    STAT · 6h agoRegulatoryPositive↗ source
  • Novartis investors grow wary as drug setbacks spark scrutiny of M&A strategy
    Investors in Novartis are intensifying their examination of the company’s recent dealmaking after a series of setbacks involving drugs that were brought in through mergers and acquisitions. The hei…
    STAT · 1h agoNegative↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 1h agoDealNeutral↗ source
  • Pro-vaccine advocates urged to add celebration to messaging after new safety data confirms flu, Covid-19 and RSV shots
    Public‑health communications consultant Adam Zimmerman argues that vaccine advocacy has lost its festive spirit and needs more fun to engage the public. He recalls the 1955 "vaccine party" when th…
    STAT · 6h agoPositive↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 3h agoRegulatoryNeutral↗ source
  • Boycott Targeting American Diabetes Association Expands to Include Medical Journal
    A new boycott has been launched against the American Diabetes Association (ADA). The campaign also calls on a medical journal to join the effort, signaling broader criticism of the organization. T…
    STAT · 3h agoNegative↗ source
  • Thoracic surgeon warns that 9/11 exposure continues to cause lung cancer and mesothelioma decades later
    Raja Flores, a thoracic surgeon at Mount Sinai, treats patients whose illnesses trace back to the dust and fumes of the World Trade Center collapse. He describes how many former first responders an…
    STAT · 6h agoNeutral↗ source
  • The future of RAS inhibitors
    Revolution Medicines recently made history with the approval of its RAS inhibitor Rasonque for advanced pancreatic cancer. But behind RevMed is an entire field of biotechs working to broaden the re…
    Fierce Biotech · 5h ago↗ source
  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 1d agoDealNegative↗ source
  • Cancer drug shortages persist at US centers, survey shows many face multiple medication gaps
    An ongoing shortage of cancer medicines is forcing leading US cancer centers to adopt work-around strategies, and a majority say clinical trials have been disrupted, a new survey reports. All cent…
    STAT · 1d agoRegulatoryNegative↗ source
  • Study finds childhood platinum chemotherapy ages liver cells, may increase future cancer risk
    A new study published in Science examined children who received platinum‑based chemotherapy, such as cisplatin or carboplatin, followed by surgery for hepatoblastoma. Researchers collected samples…
    STAT · 21h agoNegative readoutNegative↗ source
  • Novartis shareholder urges board overhaul after share plunge tied to trial setbacks
    A prominent Novartis investor has publicly called for a revamp of the company’s board, arguing that stronger governance is needed after the stock experienced a record decline. The demand was voice…
    STAT · 1d agoNegative↗ source
  • Frazier Life Sciences raises over $1.1 billion for its public biotech fund, now $2.8 billion total
    Frazier Life Sciences announced that its public fund has secured more than $1.1 billion in new capital, bringing the fund’s total assets to $2.8 billion. The fund, launched in 2021, targets small-…
    Fierce Biotech · 1d agoDealPositive↗ source
  • New FDA Oncology Center chief Angelo de Claro pledges AI integration and trial expansion
    Angelo de Claro, M.D., has taken over as the permanent head of the FDA’s Oncology Center of Excellence after serving as acting director since late 2025. In his first interview, he said the agency w…
    Fierce Biotech · 15h agoRegulatoryNeutral↗ source
  • Singapore opens biotech-focused Boston hub, strengthening ties with city
    Singapore announced the opening of its fifth U.S. overseas centre, a biotech-focused hub in Boston, during an event at the historic Raffles Hotel. Government officials and business leaders gathered…
    Fierce Biotech · 17h agoPositive↗ source
  • Two promising heart drugs fail, podcast examines why
    The latest episode of The Readout LOUD looked at two experimental therapies that had been billed as the next breakthrough in treating heart disease. The discussion highlighted how billions of dolla…
    STAT · 21h agoNegative readoutNegative↗ source
  • FDA issues partial hold on Biohaven’s experimental epilepsy drug opakalim, pausing recruitment in late-stage trial
    Biohaven announced that the FDA has placed a partial hold on its experimental epilepsy therapy, opakalim, after the company recently transferred rights to the drug in a licensing agreement. The ag…
    BioPharma Dive · 22h agoRegulatoryNegative↗ source
  • FDA expands approval for Bayer's lung cancer therapy
    The U.S. Food and Drug Administration announced an expansion of the approved use of Bayer's lung cancer drug. The decision broadens the patient population eligible for the treatment, reflecting th…
    STAT · 1d agoApprovalPositive↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 1d agoDealNegative↗ source
  • Roivant's mosliciguat shows strong efficacy in Phase 2 PH-ILD trial
    Roivant's experimental drug mosliciguat achieved strong efficacy signals in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The mid-stage trial met its…
    STAT · 1d agoPositive readoutPositive↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 1d agoPositive↗ source
  • Midterm races in Iowa, Florida and others could shape US vaccine policy
    Vaccine policy has emerged as a prominent issue in the lead‑up to the November midterms, spurred by the president and health secretary’s skeptical stance. In Iowa, the Republican candidate for gov…
    STAT · 1d agoNeutral↗ source