On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...

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 ...

Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its ...

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 ...

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 ...

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 ...

Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced that ...

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company ...

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...

Pivya ® (pivmecillinam tablets) is now available for the treatment of female patients aged 18 years and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of ...

Citi's 2026 Virtual Oncology Leadership Summit February 18, 2026 3:15 PM ESTCompany ParticipantsJean-Charles Soria - Senior Vice ...