Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting ...
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant ...
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former ...
The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...
The loss of domvanalimab is the latest in a string of high-profile failures recorded across the biopharma world for the TIGIT ...
The FDA has cleared the use of GSK’s Blujepa for the treatment of uncomplicated urogenital gonorrhea, unlocking the first new ...
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care ...
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for ...
Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called ...
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to ...
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a ...
While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy ...
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