FDA News

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.

Johnson & Johnson announced the approval of FcRn blocker nipocalimab for adults and children > 12 years who are AChR or MuSK antibody positive.

FDA further postpones action date for elamipretide, a potential treatment for Barth syndrome, as discussions on labeling progress.

This announcement by Q32 Bio Inc. highlights the Fast Track designation by the FDA granted to bempikibart (ADX-914) for alopecia areata.

This FDA approval makes pz-cel the first single application therapy to receive FDA approval for recessive dystrophic epidermolysis bullosa.

Orchestra BioMed’s Breakthrough Device designation could apply to nearly 8 million patients with uncontrolled hypertension and increased cardiovascular risk

The FDA identified no issues with the safety or efficacy of aflibercept 8 mg in any of its already approved dosing regimens or indications.

Dupilumab's approval marks the first new, targeted therapy for CSU in more than a decade and is the 7th indication for a disease with underlying type 2 inflammation.