Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.
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OTTAWA, Ontario, Aug. 09, 2024 (GLOBE NEWSWIRE) — PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine, today commented on the U.S. Food and Drug Administration (“FDA”) decision on the New Drug Application by Lykos Therapeutics for MDMA and MDMA-assisted therapy to treat PTSD. “While the FDA’s decision is a setback for the […]
Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.
LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...
The Johnson & Johnson filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of...
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....
KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...
Spring House, Pa. (August 29, 2024) – Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and...
The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.
Quezon City. The toxics watchdog group EcoWaste Coalition gave the Food and Drug Administration (FDA) a pat on the back for its recent move to...