FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5

Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical ...

Medicus Pharma Shares Rise After Filing of FDA Priority-Voucher Application

Medicus Pharma shares were 13% higher, at $2.49, after the company said it has submitted a Food and Drug Administration Commissioner's national priority-voucher application on behalf of its Skinject ...
TipRanks on MSN

Celcuity submits gedatolisib new drug application to the FDA

Celcuity (CELC) announced the completion of the submission of its new drug application to the FDA for gedatolisib in hormone receptor positive, ...
The Manila Times

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug ...
Business Wire

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...
The Manila Times

Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD

Silo Pharma, Inc. (Nasdaq: SILO) ('Silo” or 'the Company), a diversified developmental-stage biopharmaceutical and ...
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

BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®

NEW HAVEN, Conn., July 21, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in ...

FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia

Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range ...
Business Insider

Belite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant

NMPA’s response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a ...
Medscape

First New PTSD Drug in Two Decades On the Horizon?

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in ...
TipRanks on MSN

Fosun Pharma’s Subsidiary Gains Approval for New Drug Application

Shanghai Fosun Pharmaceutical (Group) Co ( (HK:2196) ) has shared an announcement.