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1,106 stories matching this filter · ← front page

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  • Trump pledges new tariffs on generic drugs not made in the US
    President Donald Trump on Tuesday evening said he will impose up to 200% tariffs on generic drugs sold in the US, if companies do not manufacture those medicines in America. Trump said that for the…
    Endpoints · 9d ago↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 9d ago↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.
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Infectious Disease253
Nephrology239
raps · 9d ago
↗ source
  • 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
  • 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…
    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
  • Agios scraps sickle cell drug
    The study failure costs Agios a chance to one-up Novo Nordisk and represents yet another setback in a disease that’s frustrated drugmakers of late.
    BioPharma Dive · 10d ago↗ source
  • Novo sues Lilly, alleging ‘misleading’ advertising of obesity drugs
    The lawsuit follows a cease-and-desist request and argues Lilly is using “deceptive” ads to claim its GLP-1 products are broadly superior to Novo’s medicines. Lilly countered that its campaign is “…
    BioPharma Dive · 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
  • Dimension restocks with $800M to capitalize on AI’s ‘rapid ascent’
    The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.
    BioPharma Dive · 10d ago↗ source
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    BioPharma Dive · 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
  • 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d 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 · 10d ago↗ source
  • Tempus to acquire cancer test maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 11d ago↗ source
  • Tempus to buy cancer test-maker Personalis for $1.5B
    Tempus AI’s planned acquisition follows recent interest in blood-based cancer tests across the medtech industry.
    BioPharma Dive · 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