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 ...

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

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 ...

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with ...

Ocular Therapeutix's current wet AMD treatment is dominated by anti-VEGF drugs, with EYLEA holding a 63% global market share in 2024. Read why OCUL stock is a sell.

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, ...

Moderna MRNA shares plunged around 10% in after-hours trading following the announcement that the FDA’s Center for Biologics Evaluation and Research (CBER) has issued a Refusal-to-File (RTF) letter ...

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

Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration has taken an aggressive stance against mRNA ...

The Food and Drug Administration last week refused to review Moderna’s application for its messenger RNA flu vaccine, in a ...

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. | The FDA specifically ...

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