HER2, a HER2-targeted immunotherapy, with plans for FDA submission following promising Phase 2b data in osteosarcoma.
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...
Travere Therapeutics aims to seek traditional approval based on data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI, with submission expected by the end of the first quarter of 2025. The ...
Reports of impending layoffs, a buyout offer, and a return-to-office mandate have put a damper on FDA staff morale ...
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Moleculin Biotech (MBRX) has received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 ...
A federal judge has ordered the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) to restore access to public health websites that were removed or modified in ...
FDA aligned on single-arm Phase 3 study to support potential accelerated and full approval On track to dose first patient in Phase 3 trial in second half of 2025 LONDON, Feb. 03, 2025 (GLOBE NEWSWIRE) ...
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Boca Raton, Florida Wednesday, February 12, 2025, 16:00 Hrs [IST] ...
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