[ Price : $8.95]
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type...[ Price : $8.95]
FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...[ Price : $8.95]
FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (...[ Price : $8.95]
FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contra...[ Price : $8.95]
FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Verte...[ Price : $8.95]
The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streaml...[ Price : $8.95]
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo...[ Price : $8.95]
Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, T...