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910 stories matching this filter · ← front page

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  • MHRA touts uptick in approvals in 2025-2026 annual report
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs tha…
    raps · 10d ago↗ source
  • Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
    Welcome back to another edition of Endpoints Weekly! We hope you all have been staying safe indoors as the Canadian wildfires blanketed much of the US Northeast this week. Hopefully things calm dow…
    Endpoints · 12d ago↗ source
  • Midsized biotechs press White House to drop CMS pricing rules
    A number of midsized biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and sho…
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Endpoints · 12d ago
↗ source
  • Celcuity got its cancer drug approved. Then its stock dipped
    The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...
    Endpoints · 12d ago↗ source
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    BioPharma Dive · 12d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 12d ago↗ source
  • GSK plans large study to see if shingles vaccine can prevent dementia
    LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less l…
    Endpoints · 12d ago↗ source
  • Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
    Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, k…
    Endpoints · 12d ago↗ source
  • Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
    The new lawsuits add to a web of legal disputes over technology involved in COVID vaccines. Elsewhere, a prolific AI biotech inked another deal and Insmed strengthened support for a closely watched…
    BioPharma Dive · 13d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 13d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    Despite an FDA crackdown, numerous pharma lawsuits and possible safety risks, nearly 1 in 5 patients are still taking cheaper weight-loss alternatives.
    BioPharma Dive · 13d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    Mixed Phase 3 data for camlipixant prompted the British pharma to cease development, making the drug the third from its class to fail.
    BioPharma Dive · 13d ago↗ source
  • How well are AI-discovered drugs faring in the clinic?
    Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.
    BioPharma Dive · 13d ago↗ source
  • GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout
    In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC) after the drug ...
    Endpoints · 13d ago↗ source
  • Zealand Pharma gets its US marketing leader from Lilly; Bexorg turns to Biohaven for CSO hire
    → Silvia Luque announced on LinkedIn that she was named head of US marketing at Zealand Pharma after 13 years in various roles at obesity competitor Eli Lilly. She had been ...
    Endpoints · 13d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the hig…
    raps · 13d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…
    raps · 13d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…
    raps · 13d ago↗ source
  • Mirador unveils part of pipeline with drug from Kira to rival Tavneos
    Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached a…
    Endpoints · 13d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    The latest in a prolific streak of buyouts by Lilly is the strongest sign yet that large pharmaceutical companies may finally be embracing a long-dismissed field of research.
    BioPharma Dive · 13d ago↗ source
  • What health system execs are talking about
    Earlier this week, I swung by the American Hospital Association’s Leadership Summit in downtown Denver. When I wasn’t giving out ice cream recommendations, I was trying to get a sense of what hospi…
    Endpoints · 13d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    The Phase 2 data exceeded expectations, lifting company shares as high as nearly $130 apiece and building the case for what may be the first pill specifically approved for female pattern hair loss.
    BioPharma Dive · 13d ago↗ source
  • Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos
    Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan succ…
    Endpoints · 13d ago↗ source
  • Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease
    LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone wit…
    Endpoints · 13d ago↗ source
  • US drug shortages rise for third straight quarter, hurt by lone suppliers
    The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
    Endpoints · 14d ago↗ source