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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.
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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
Two biopharma companies developing therapeutics in the oncology space begin the week with strong signals in Phase II.
Sigilon Therapeutics announced it may have discovered the reason why its experimental cell therapy treatment for severe hemophilia A was placed on clinical hold by the FDA.
Omicron has caused the U.S. to install travel bans against several South African countries while vaccine makers rush to test their vaccines against it. For that news and more, continue reading.
The deal adds LNG-451, a highly selective brain-penetrant precision therapy targeting EGFR exon 20 insertion mutations, to its pipeline.
New York-based Turnstone Biologics announced it is partnering with the Moffitt Cancer Center to develop tumor-infiltrating lymphocyte (TIL) therapies.
Results from its GEM-3 trial on VYJUVEK demonstrated statistical significance in its ability to promote complete wound healing within six months compared to a placebo.
In October, Vertex Pharmaceuticals announced stunning results in a type 1 diabetes patient who had been dosed with the company’s experimental therapy.
As the late-stage trials continue to progress, Talaris is rapidly ramping up its resources and investments.
The latest data from Merck and Ridgeback Biotherapeutics’ MOVe-OUT trial on the use of molnupiravir to treat COVID-19 in adults has shown a lower efficacy than previously reported.
Treatment for non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease, consists mainly of lifestyle modification – specifically dieting and weight loss.