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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.
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CStone forged a licensing agreement with Jiangsu Hengrui Pharmaceuticals that grants the company access to a monoclonal antibody aimed at multiple forms of cancer.
Switzerland-based Vifor Pharma is acquiring Spain’s Sanifit Therapeutics and another Swiss company, Inositec.
The beginning of booster vaccines for adults was in news for a long time. Well, CDS authorized it now, and here’s the reason behind the authorization.
“I hope to thread the needle between pricing responsibly and achieving profitability,” Jarrett said.
The U.S. Food and Drug Administration has a few PDUFA dates for the Thanksgiving Holiday week. Here’s a look.
A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military.
BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.
The two dominant theories over the origins of COVID-19 are that the virus developed naturally, probably from bats in a wet market in Wuhan, China, and the “lab leak.”
If the road to success is paved with failures, then the road to an effective, approved drug is paved with flops. Merck and Enanta are adding some painful pavers to their own roads this week.
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.