Travere, Ligand Pharma announce FDA label expansion for Filspari

Shares of Travere Therapeutics (TVTX) and Ligand Pharmaceuticals (LGND) traded higher in the premarket on Tuesday after the FDA approved a label expansion for their jointly developed kidney disease ...
Healio

FDA approves Vabysmo label update for macular edema due to retinal vein occlusion

The FDA approved an updated label for Vabysmo for the treatment of macular edema following retinal vein occlusion beyond 6 ...
Cure Today

FDA Approves CAR T Therapy Label Updates Across Various Blood Cancers

FDA-approved updates for Breyanzi and Abecma reduce patient monitoring and eliminate REMS, enhancing access to CAR T-cell therapies. Labeling changes reflect increased regulatory confidence in the ...
The National Law Review

Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label

PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update ...
Seeking Alpha

Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes

RICHMOND, Va., Feb. 12, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative ...
Nasdaq

Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection

Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm ...