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 ...

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.
TipRanks on MSN

Nuvalent’s New Drug Application for zidesamtinib in NSCLC acepted by FDA

Nuvalent (NUVL) announced the FDA has accepted for filing its New Drug Application, or NDA, for zidesamtinib, an investigational ROS1-selective ...
Healio

FDA accepts new drug application for sublingual epinephrine film

Please provide your email address to receive an email when new articles are posted on . Aquestive Therapeutics’ Anaphylm sublingual film is about the size of a postage stamp. Anaphylm’s time to ...
Fierce Biotech

Applied Tx lays off 46% of workforce as rare disease drug approval looks out of reach

While the board considers which path to take, it is implementing various “cost-containment and cash conservation measures,” ...
CURE

FDA Grants Fast Track Status to New Gastric Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate ...
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, ...
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 ...
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 ...
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 ...
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 ...
The Manila Times

SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK

GSK remains committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones as well as royalties, net of payments to ...