Drug to treat rare pediatric disease accepted for FDA review
A subsidiary of a Miami-based company is inching closer to FDA approval for a drug that treats a rare pediatric disease.
JD Supra2d
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 ...
The Norman Transcript12h
New drug development tool could revolutionize industry
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could ...
Zacks.com on MSN10d
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 ...
Healio2d
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 ...
Business Wire11d
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, ...
MarketWatch11d
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 ...
Shanghai Junshi’s JS212 Drug Application Accepted, Boosting Cancer Therapy Pipeline
Discover outperforming stocks and invest smarter with Top Smart Score StocksFilter, analyze, and streamline your ...
JD Supra11h
Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing
The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims ...