infectiousdiseaseadvisor.com3h
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
JD Supra1d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
Zacks.com on MSN9d
Corcept Submits Application for Another Cushing's Syndrome Drug
Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...
Healio1d
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
MarketWatch9d
Corcept Therapeutics Submits New Drug Application for Cushing's Sydrome Treatment
Corcept Therapeutics submitted a new drug application to the Food and Drug Administration for its treatment of hypercortisolism, or Cushing's syndrome, a hormonal disorder that occurs when the ...
Business Wire9d
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of R…
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...
AMD invests $20M in AI-powered drug discovery company Absci
Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...
Vanda asserts FDA review of tradipitant was flawed
Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...