Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...

COMPASS Pathways (NASDAQ:CMPS) used an investor update webinar to highlight positive results from its Phase III COMP005 and ...

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

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 ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.

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 ...

The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...

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 ...

This is our FDA today. Quack nostrums get approved based on “incredible stories”, while vaccines get dismissed out of hand despite multiple successful RCTs. Our FDA leaders call this “ gold-standard ...

Enrollment for 4FRONT-1, the first registrational trial for 4D-150 in wet AMD, was completed within an approximately 11-month period, ahead of ...

Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release outlining the ...