Argenx wins FDA nod to broaden Vyvgart label in myasthenia gravis

The U.S. FDA has approved a label expansion for Vyvgart and Vyvgart Hytrulo in myasthenia gravis, letting a broader section of adults suffering from the autoimmune disease receive the therapy, its ...
Medscape

FDA Expands Vyvgart Approval to All Adults With gMG

The label expansion will include adults with AChR-Ab-negative gMG, making efgartigimod the first and only approved treatment for all serotypes of the rare neuromuscular disease.
Fierce Pharma

FDA floats possible approach to repurpose approved drugs under new uses

The framework would leverage existing safety data on approved drugs to provide new options to patients with unmet medical ...
Nasdaq

MannKind Secures FDA Approval For Updated Afrezza Label Enhancing Dose Conversion Guidance

(RTTNews) - MannKind Corporation (MNKD) announced that the U.S. FDA has approved an update to the Afrezza prescribing information, adding new guidance for determining the starting mealtime dose when ...
Healio

FDA approves updated label with new dosing guidance for inhaled insulin

Please provide your email address to receive an email when new articles are posted on . A revised technosphere insulin label recommends patients start using the therapy at a higher dose than ...

Axsome wins FDA label expansion for Auvelity in Alzheimer’s agitation

Axsome Therapeutics (AXSM) stock is in focus as the FDA OKs a label expansion for the firm's depression drug Auvelity in ...
Business Wire

U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on ...

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

ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older

ADMA Biologics, Inc. (Nasdaq: ADMA) ('ADMA” or the 'Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, ...
Healio

FDA updates Winrevair indication in PAH, highlighting impact in high-risk patients

Please provide your email address to receive an email when new articles are posted on . This decision was based on phase 3 ZENITH trial data assessing Winrevair in adults with WHO functional class III ...
Seeking Alpha

Cytokinetics, Incorporated (CYTK) Discusses FDA Approval of MYQORZO for Symptomatic Obstructive Hypertrophic Cardiomyopathy Transcript

Good day, everyone. My name is Leila, and I will be your conference operator today. At this time, I would like to welcome you to Cytokinetics conference call for the FDA approval of MYQORZO. [Operator ...