Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and ...

Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, announced today that ...

Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives ...

Disc is seeking accelerated approval and priority review of its NDA submission FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 ...

A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...

HK Innoen announced on January 13 that Braintree, a subsidiary of its U.S. partner company Sebela Pharmaceuticals, submitted ...

Vanda Pharmaceuticals announced it received a decision letter from the FDA’s Center for Drug Evaluation and Research (CDER) stating that the supplemental New Drug Application (NDA) for Hetlioz ...

James V. Caruso, President and CEO, stated that Cellectar has made "significant strides across our development pipeline, regulatory strategy, corporate development initiatives and fundraising efforts, ...

The FDA's complete response letter for Dasynoc was due to manufacturing issues, delaying its approval for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) treatment. Dasynoc, a ...

Corcept Therapeutics CORT announced that the FDA has accepted the new drug application (NDA) seeking approval for its lead pipeline candidate, relacorilant, for treating patients with ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...