COMPASS Pathways (NASDAQ:CMPS) used an investor update webinar to highlight positive results from its Phase III COMP005 and ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...
Deupirfenidone, a potential new treatment for idiopathic pulmonary fibrosis, is set to be tested in a phase 3 trial this year after a successful phase 2b trial and meeting with the FDA, according to a ...
US FDA accepts Roche’s NDA for giredestrant in ESR1-mutated, ER-positive advanced breast cancer: Basel Saturday, February 21, 2026, 11:00 Hrs [IST] Roche announced that the Unit ...
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, ...
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for ...
FDA accepts Moderna's revised mRNA flu vaccine application eight days after refusal, setting August 2026 decision deadline for potential seasonal availability.
The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have ...
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its ...
Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release outlining the ...
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