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  • FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
    The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
    fda press · 7d ago↗ source
  • Crystalys gets $130M to take Sobi-rivaling gout drug to market
    A San Diego biotech has raised an additional $130 million to get a gout drug that's already approved in Japan and China onto the US and European markets. Crystalys Therapeutics reeled in the Series…
    Endpoints · 7d ago↗ source
  • Summit reports two-year survival data for Western patients, though context lacking
    Summit Therapeutics unveiled additional follow-up data on its experimental cancer drug ivonescimab, and how its benefit compares between Asian and Western patients. But key context remains unknown.…
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Endpoints · 7d ago↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Topli…
    Endpoints · 7d ago↗ source
  • Biopharma dealmaking in 2026: The recovery gathers speed in Q2
    It’s always darkest before the biotech dawn, and at no time was that more true than last summer, as biotech was experiencing a crisis of confidence. We tracked an industry-wide downturn in expectat…
    Endpoints · 7d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 7d ago↗ source
  • Vertex was only bidder for Crinetics in year's second-highest M&A premium
    To gain control of Crinetics Pharmaceuticals, Vertex Pharmaceuticals was willing to pay the second-highest premium so far in biopharma's banner year for M&A. And the Boston drugmaker was bidding ag…
    Endpoints · 7d ago↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 7d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 7d ago↗ source
  • 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 · 7d 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 · 8d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 8d 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 · 8d ago↗ source
  • Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge
    A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…
    Fierce Biotech · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d 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 · 8d ago↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 8d ago↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 8d 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 · 8d 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 · 8d ago↗ source
  • Jupiter enters psychedelics space with $100M deal for PharmAla's MDMA drug
    Jupiter Neurosciences will pay $3.3 million upfront to Canada's PharmAla Biotech for U.S. rights to an MDMA drug to treat neuropsychiatric disorders.
    Fierce Biotech · 8d ago↗ source
  • Agios says adios to sickle cell program over lackluster phase 2 data
    A phase 2 study of Agios Pharmaceuticals’ next-generation pyruvate kinase activator has failed to support continued development in sickle cell disease, leading the company to ax an indication for t…
    Fierce Biotech · 8d ago↗ source