Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Nature Reviews Drug Discovery - The FDA approved 50 new therapeutics in 2024, with green lights for a novel schizophrenia drug, ... reportedly due to issues at a third-party manufacturing facility.

Issues. May 2025, Medicaid ... Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, approved the drug under the FDA’s accelerated approval pathway for a subset of ...

With the first quarter of 2022 now in the rear-view mirror, the FDA has approved 10 new drugs (Table 1), 4 short of the total this time last year. The decline might add fuel to speculation that ...

Biogen was expecting a population of around 1 million to 2 million patients to be eligible for the drug. Instead, the FDA approved the drug under a much broader label, making all 6 million U.S.