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.

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, Inc.: 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/ ...
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 ...
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 ...
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 ...
Health Affairs

Follow-On Cancer Drugs Target Earlier Stages Than Initial Drugs: Implications Of The IRA

The Inflation Reduction Act (IRA) of 2022 mandates price negotiations for certain drugs under Medicare, shortening the exclusivity period historically used to recoup research and development ...
The Bakersfield Californian

ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and D ...
JD Supra

FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics

The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of ...

Celcuity Inc.: 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 ...
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 ...

FDA Offers Up New Pathway for Drugs That Can't Clear Normal Approval Hurdles

Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I ...