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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
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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.
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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
Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.
Avilar Therapeutics officially joined the game with $60 million in seed financing from RA Capital Management.
The Richard King Mellon Foundation has awarded a $100 million gift to the University of Pittsburgh and approved a $150 million grant for Carnegie Mellon University.
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
Novo Nordisk and Dicerna are no strangers. The companies have been collaborating on the development of RNAi therapies for liver disease for the past three years.
The strategic collaboration entails a $180 million equity investment into Owkin and a total payment of $90 million over the next three years, in addition to milestone-based fees to be determined later.
Finding a job in the pharmaceutical industry can be challenging. Find out which skills can help you score your dream pharmaceutical company job.
The U.S. Securities and Exchange Commission has launched an investigation into Texas-based Cassava Sciences.
Her career as a physician and scientist is guided by a combination of logic and creativity.
Biopharma and life sciences companies from across the globe provide updates. Belgium-based Galapagos NV won European approval for Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).