Experts say the FDA "moved the goalposts" on Moderna, creating "a destructive precedent that will undermine the future of ...

On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...

NovoCure secures FDA approval for Optune Pax in first-line locally advanced pancreatic cancer, first such approval in three ...

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.

Treatments for acquired hypothalamic obesity, dry eye disease, primary biliary cholangitis, psoriatic arthritis, and severe leukocyte adhesion deficiency-I under review.

The pivotal Phase 3 AD clinical trial of buntanetap ( NCT06709014) is currently recruiting patients across the United States and is now 40% complete. The first symptomatic efficacy readout is ...

Prasad changed jobs but his conservative regulatory doctrine remains the same, particularly for cell and gene therapies. The ...

Feb 12 (Reuters) - French drugmaker ⁠Sanofi ⁠said on Thursday ⁠it had appointed Belén Garijo as its new ​chief executive ...

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

In addition to Bank of America Securities, Novavax also received a Sell from Citi’s Geoff Meacham in a report issued on January 30. However, on February 3, TipRanks – Google reiterated a Hold rating ...

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