News
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Seven biopharma companies are under new leadership. This week’s Movers & Shakers highlights these new chief executive officers who aim to guide their companies into the future.
Novartis outlined how its transformation to a pure-play innovative medicines company is nearly completed during a “Meet the Management” event in Switzerland.
The 7th Annual CAR-TCR Summit is ongoing in Boston, with more than 1,000 experts in CAR and TCR technologies attending. Here’s a look at some of the latest research and data being presented.
Alaunos Therapeutics, Satsuma Pharmaceuticals, NeuroSense, Emyria and more reported updates in solid tumors, migraine, ALS and MDMA drug discovery.
Allogene Therapeutics’ French partner Servier has withdrawn all involvement in the development of Allogene’s anti-CD19 products, allowing Allogene to license its CD19 products outside the U.S.
Shares of Spero Therapeutics soared in premarket trading following GlaxoSmithKline’s announcement that it will license the company’s late-stage antibiotic asset, tebipenem HBr.
New data from Novo Nordisk’s Phase IIIa ONWARD 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes.
Rivus raised $132 million in a Series B financing round that will be used in developing HU6, a new drug class designed to treat cardio-metabolic disease by addressing obesity.
Carisma Therapeutics is merging with Sesen Bio to advance Carisma’s cell therapy platform - in particular, its chimeric antigen receptor macrophage (CAR-M) therapies.
Celltrion agreed Wednesday to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could net as much as $1.75 billion. See inside for more cancer collaborations.