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FDA clears investigational new drug application to test sCAR-T therapy for autoimmune conditions

Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the ...

Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricides

SHELTON, CT / ACCESS Newswire / April 7, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) ...

NX Development Corp Submits Supplemental New Drug Application to FDA for MEN-301 Study

LEXINGTON, KY / ACCESS Newswire / April 6, 2026 / NX Development Corp (NXDC) is pleased to announce that after ...
Targeted Oncology

New Drug Application Submitted for Neladalkib in Advanced ALK+ NSCLC

Nuvalent has submitted an NDA to the FDA for neladalkib, a brain-penetrant ALK-selective TKI for pretreated advanced ...

Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

FDA assigned PDUFA target action date of September 27, 2026 BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Praxis Precision ...
Nasdaq

BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines ...

Nuvalent, Inc.: Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC

New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 2026 /PRNewswire/ ...
Cure Today

FDA to Review New Drug Combo for Previously Treated Metastatic Colorectal Cancer

Zanzalintinib plus Tecentriq showed improved survival in metastatic colorectal cancer patients compared to Stivarga in the STELLAR-303 trial. The FDA accepted the new drug application for this ...
Nasdaq

Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...