Healio

FDA accepts new supplemental biologics license application for review for Winrevair

Please provide your email address to receive an email when new articles are posted on . Phase 3 ZENITH trial data assessing Winrevair in adults with WHO functional class III or IV PAH support the new ...

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG

AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to ...

Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting ...
Cure Today

FDA Accepts Supplemental New Drug Application for Cabometyx in Pancreatic NETs

The FDA will review an application for Cabometyx as a potential treatment for pancreatic neuroendocrine tumors after findings from a phase 3 trial. A supplemental new drug application has been ...
Healio

FDA accepts supplemental application for Zoryve foam for scalp, body psoriasis

Please provide your email address to receive an email when new articles are posted on . The FDA accepted the supplemental new drug application for Zoryve foam 0.3% to treat adults and adolescents with ...
The Manila Times

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

NDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home ...
Seeking Alpha

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, 2026 If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in ...
Becker's ASC

Synergy Pharmaceuticals submits supplemental new drug application for Trulance: 5 insights

New York City-based Synergy Pharmaceuticals submitted a supplemental New Drug Application for Trulance. Here’s what you should know. 1. Trulance was FDA approved in adults with chronic idiopathic ...
Seeking Alpha

FDA Accepts BioMarin's Supplemental New Drug Application to Expand Use of VOXZOGO® (vosoritide) for Injection to Treat Children with Achondroplasia Under the Age of 5

SAN RAFAEL, Calif., March 7, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that ...
Nasdaq

Amgen Submits Supplemental New Drug Application for Otezla® (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis

--Amgen today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Otezla ® for the treatment of adults with mild-to-moderate plaque psoriasis ...

BioArctic: Leqembi Iqlik (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous ...