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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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Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
In a filing with the SEC, Abbvie’s decision to terminate came after the two firms jointly conducted a review of their next steps for the drug.
With one in three employed women in the U.S. also raising children at home, and the majority of U.S. moms working at least part-time, moms are working overtime to keep up with their male counterparts.
Ramesh “Sunny” Balwani, Elizabeth Holmes’ former business and romantic partner, was found guilty of all 12 fraud charges brought against him for his role in the Theranos scandal.
Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
With COVID-19 vaccination rates dropping, millions of doses are going to waste. Meanwhile, outdoors isn’t sure-fire protection but long-term intermittent fasters may be spared severe disease.
Adagio, Aravive, PolyPid, Harpoon, Durect, Nitrase, Kallyope, TScan and many more made major leadership decisions this week.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
When GSK’s consumer health spinoff Haleon launches later this month, the new business will carry more than $12 billion in debt when it lists on the London Stock Exchange.
Portage Biotech announced Wednesday that it has inked an acquisition agreement with New York-based Tarus Therapeutics, adding four new candidates to its pipeline.