USA Today

Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides

According to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products). “NV ...
Business Insider

Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing ...
MarketWatch

FDA Sees Deficiencies in Aquestive Therapeutics Drug Application

Aquestive Therapeutics said the Food and Drug Administration identified deficiencies in its new drug application for Anaphylm, an orally administered treatment for severe allergic reactions. Shares ...
Benzinga.com

Aquestive Stock Slides After FDA Flags Issues With Allergy Drug Application

The company on Friday said the U.S. Food and Drug Administration (FDA) has identified deficiencies in Anaphylm’s New Drug Application (NDA) that preclude discussion of labeling and post-marketing ...
The Business Journals

FDA rejects Vanda's jet lag drug application days after approving motion sickness drug

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The rejection came just a week ...
Hosted on MSN

Abpro Holdings submits IND application for cancer drug

An announcement from Abpro Holdings ( (ABP)) is now available. On December 15, 2025, Abpro Holdings, Inc. announced the submission of an investigational new drug (IND) application to the U.S. FDA for ...
Business Wire

Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a New Drug Application ...
Morningstar

Nuvalent Files New Drug Application for Lung Cancer Treatment With FDA

Nuvalent filed a new drug application for an experimental non-small cell lung cancer treatment with the Food and Drug Administration. The clinical-stage biopharmaceutical company on Wednesday said the ...
Seeking Alpha

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

NDA based on data from global ARROS-1 Phase 1/2 clinical trial FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (NUVL) (Nasdaq: ...
FiercePharma

FDA avoids the worst amid government shutdown, but new applications put on hold

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...
Cure Today

FDA Accepts New Drug Application for Relacorilant in Ovarian Cancer

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
Nasdaq

FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe ...