JD Supra11h
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 ...
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 ...
Healio17h
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 ...
Zacks.com on MSN8d
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 ...
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, ...
JD Supra13d
CAFC Decision on Orange Book Listings for Drug/Device Combination Patents
On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded ...
Managed Healthcare Executive1d
WHO to Develop Lenacapavir and HIV Testing Guidelines
A Guideline Development Group (GDG) meeting at the end of the month aims to establish new guidelines for lenacapavir, a twice ...