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986 stories matching this filter · ← front page

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  • Novo sues Lilly over 'deceptive' ads comparing GLP-1 drug doses
    The two biggest players in the obesity market are headed to court. Novo Nordisk sued Eli Lilly on Tuesday over what it claims are “maliciously and deceptively false” ads comparing the highest doses…
    Endpoints · 10d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
    BioSpace · 10d ago↗ source
  • PT Organics Limited Recalls Select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree Pouches Due to the Potential for Soft Plastic to Enter the Finished Product
    July 21st, 2026, PT Organics Limited of Lake Oswego, Oregon is voluntarily recalling select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches because of an internal packa…
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fda recalls · 10d ago↗ source
  • Indian generic drugmaker gets FDA warning over clinical study consent
    Indian generic drugmaker Alembic Pharmaceuticals has been hit with an FDA warning letter after failing to get informed consent from patients for a clinical study. In a breakaway from typical FDA wa…
    Endpoints · 10d ago↗ source
  • FDA plans to name permanent center heads alongside FDA chief
    The FDA is planning to announce a slate of senior personnel announcements when a new commissioner is named, including permanent heads of CBER and CDER, according to three sources familiar with the…
    Endpoints · 10d ago↗ source
  • Novartis CEO says latest China deals are just following the science
    Novartis isn't making deals in China just for the sake of buying there. That's the word from CEO Vas Narasimhan, who told reporters on a second-quarter earnings call that the Swiss pharma is “agnos…
    Endpoints · 10d ago↗ source
  • Gilead and Merck provide HIV data; Dimension Capital announces $800M fund
    Gilead and Merck’s HIV data: The duo will present more detailed results of the Phase 3 trials of their once-weekly oral HIV treatment regimen at AIDS 2026, one of the largest ...
    Endpoints · 10d ago↗ source
  • Agios’ second shot at sickle cell disease falls short
    Agios said it is dropping a next-generation sickle cell disease drug after lackluster results from a mid-stage trial. The drug, known as tebapivat, represented Agios’ second shot at the disease, an…
    Endpoints · 10d ago↗ source
  • Notes from a peptide meetup
    With an FDA advisory committee set to decide this week whether it recommends that several popular peptides be reclassified, I wanted to learn more. Cue a last-minute ticket purchase to ...
    Endpoints · 10d ago↗ source
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 10d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 11d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 11d ago↗ source
  • Broad Institute launches Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard is teaming up with Boston Children’s Hospital and The Jackson Laboratory to launch a new center focused on genetic treatments for rare diseases, the triumvira…
    Endpoints · 11d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 11d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 11d ago↗ source
  • A-Alpha Bio starts AI antibody data consortium with GSK, Boltz
    Biopharma's AI engines need more data. And David Younger thinks there's a great business to sell those data to them. Younger's startup, A-Alpha Bio, has spent months studying how protein-designing…
    Endpoints · 11d ago↗ source
  • Fresh & Ready Foods LLC Recalls Spicy Breakfast Burrito due to Undeclared Soy
    Charlotte, N.C. - Fresh & Ready Foods LLC is recalling a limited number of Sprig & Sprout Spicy Breakfast Burrito and Fresh and Ready Spicy Breakfast Burrito because they may contain undeclared soy…
    fda recalls · 11d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 11d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to s…
    raps · 11d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, in…
    raps · 11d ago↗ source
  • UnitedHealth Group lays out progress in AI push
    After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insure…
    Endpoints · 11d ago↗ source
  • House lawmakers back trade probe of China biotech, sequencing
    At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the U…
    Endpoints · 11d ago↗ source
  • Samsung Bio to step into peptides in $1.8B buy for PolyPeptide
    Samsung Biologics is set to branch out to peptide ingredient manufacturing with plans to buy Swiss CDMO PolyPeptide for $1.8 billion in cash. The purchase, announced Monday, would be the Korean ...
    Endpoints · 11d ago↗ source
  • Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition
    A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...
    Endpoints · 11d ago↗ source
  • Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
    Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
    Endpoints · 11d ago↗ source