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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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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
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.
Annexon released final data from an open-label phase II clinical trial, showing that its drug candidate ANX005 safely stabilized disease progression in patients with Huntington’s disease.
The Tisch MS Research Center of New York has been researching the concept of using cell therapy as a therapeutic strategy to promote repair and regeneration in certain patients with MS.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Aslan partners with Johns Hopkins and Duke, Editas joins forces with Immatics, Yumanity (soon to be Kineta, Inc.) teams with Janssen, Serotiny & Janssen Biotech and Ginkgo and Novo Nordisk.
Amarin and Vincerx Pharma intend to restructure their financial strategies and lessen operational costs by trimming their employee rosters.
Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.
The Phase I mechanism of action study, showing that Lilly’s injectable Mounjaro (tirzepatide) induces greater weight loss than placebo and Novo Nordisk’s semaglutide in adults with type 2 diabetes.
Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting a potential of more than 80 new regulatory approvals in oncology through 2028.