In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal ...
As clinical research evolves, disruptive trial designs are reshaping how oncology advances. By integrating novel ...
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 ...
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 ...
The loss of domvanalimab is the latest in a string of high-profile failures recorded across the biopharma world for the TIGIT ...
The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...
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 ...
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to ...
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