On December 24, 2025, Sanofi announced that the US Food and Drug Administration issued a complete response letter for its new drug application for tolebrutinib to treat non-relapsing secondary ...

Early Thursday, Takeda revealed top-line data for two pivotal phase 3 trials of its next-gen, highly selective oral tyrosine ...

Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking ...

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...

A Regeneron Pharmaceuticals drug that lowers levels of a disease-driving protein has met the goals of a pivotal test in the rare disease generalized myasthenia gravis. Based on these results, ...

The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.

Immunome’s investigational oral therapy has slashed the risk of disease progression or death by 84% for patients with desmoid ...

Transplants can trigger EBV reactivation, leading to EBV-positive PTLD, with poor survival if rituximab fails. Tabelecleucel (tab-cel) shows promise in treating refractory EBV+ PTLD, with significant ...

CAMBRIDGE, Mass., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB) and Sage Therapeutics, Inc. (SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted the filing ...