The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

On the basis of these findings, VSTM has pursued approval through a rolling NDA, completed in Q4 2024. Now, the big news is out and has already been digested by the market. The FDA accepted the ...

Ascendis positioned to drive rapid revenue growthCOPENHAGEN, Denmark, Jan. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) ...

Key Takeaways JNJ will buy Intra-Cellular Therapies, producer of a drug for bipolar disorder, for $14.6 billion. Eli Lilly ...

Chairman of the Board, Wei Fu, informed the Company of his intent to purchase up to $2,000,000 of the Company's American Depository Shares (ADSs) Wei Fu, Chairman of the Board of I-Mab and Chief ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, ...

He added that developers must plan well in advance (at the end of Phase II or before submitting an NDA or BLA) for complex REMS, to allow the possibility for a first-cycle approval of the NDA or BLA.

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They ...

Phase 2 randomized study of ELI-002 fully enrolled, with formal interim analysis of disease-free survival ("DFS”) expected in ...