FDA News

The label expansion makes glecaprevir/pibrentasvir the first and only oral 8-week pangenotypic treatment option approved for people with acute or chronic HCV.

If approved, mavorixafor will be the second FDA-approved treatment and the first oral medication for CN.

FDA approves the new therapy under the name Enflonsia, offering effective RSV prevention for infants during their first RSV season.

Richard Lafeyette, MD, discusses his reaction to the phase 3 ORIGIN topline results and what it means for IgAN.

Sciurba shared his excitement for the recent approval of mepolizumab for people with COPD and an eosinophilic phenotype.

Discover key advancements and setbacks in cardiovascular medicine from May 2025, shaping the future of cardiometabolic care and treatment options.

This May was characterized by HCPLive’s coverage of the ARVO and Envision conferences, as well as a slew of FDA approvals towards the end of the month.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and new treatment guidelines, in this week's essential news roundup.

TRYPTYR, formerly AR-15512, displayed rapid onset and sustained tear production in its pivotal Phase 3 trials in 2024.

The FDA approves hydrocortisone oral solution for pediatric adrenal insufficiency, enhancing dosing accuracy and ease for young patients and caregivers.

With the priority review acceptance of the Biologics License Application, the FDA has assigned a PDUFA target action date of November 28, 2025.

The FDA approves treprostinil inhalation powder, enhancing treatment options for patients with pulmonary arterial hypertension and interstitial lung disease.

The FDA approves mepolizumab as a new maintenance treatment for COPD, showing significant reduction in exacerbations for specific patients.

Discover innovative treatments for plaque psoriasis that cater to diverse skin tones, offering effective relief without the risk of discoloration.

This approval of roflumilast foam as a once-daily topical treatment for psoriasis of the scalp and body followed the phase 3 ARRECTOR study findings.

Susvimo is the first FDA-approved continuous delivery treatment for diabetic retinopathy capable of maintaining vision through one refill per 9 months.

Early data on Selagine, Inc.’s immunoglobulin eye drops have indicated significant reductions in DED symptoms without differences in adverse events or tolerability.

The approval adds to Ritestar’s currently approved albuterol sulfate 2.5 mg/3 mL (0.083%), 1.25 mg/3 mL, and 0.63 mg/3 mL strength products.

The allergy medications of cetirizine or levocetirizine have led to pruritus in some patients who stopped using the medications after using them daily for a few months or years.

LED BLU-U, used in combination with LEVULAN KERASTICK, is capable of treating minimally to moderately thick actinic keratoses.

With the sNDA acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.

FDA accepts BioCryst’s NDA for berotralstat oral granules in kids with HAE; priority review granted. Approval could bring first oral prophylactic for kids aged <12 years.

FDA approves 12.5 mg chlorthalidone tablets, enhancing hypertension treatment options and aligning with clinical guidelines for better patient outcomes.

The FDA accepted the NDA for oral semaglutide 25 mg, a potentially revolutionary daily treatment for weight management and cardiovascular risk reduction.

April sees mixed outcomes in FDA approvals, with promising gene therapies advancing while others face setbacks, highlighting ongoing challenges in ocular treatments.