FDA News

MannKind Therapeutics has announced new starting dose recommendations for patients with type 1 diabetes switching from injected or insulin pump mealtime therapy.

Higher accuracy lung biopsy could make a strong impact on lung cancer diagnoses and outcomes.

Berotralstat becomes the first once-daily oral prophylactic option for long-term prevention of hereditary angioedema in children aged 2–11 years.

Despite an OTC approval in 2023, recent data highlights a carry rate of only 10% in the general population.

The FDA has extended its review of the sNDA, delaying the previous January 13, 2026, PDUFA date, to April 13, 2026.

An FDA review found no increased risk of SI/B associated with the use of GLP-1 RA medications, including liraglutide, semaglutide, and tirzepatide.

The KAI 12L program is now cleared to determine short PR interval, atrial bigeminy, ventricular bigeminy, left axis deviation, and right axis deviation.

Neurolief’s physician-directed therapy brings supervised, noninvasive brain stimulation into the home for adults with MDD who have not responded to ≥ 1 antidepressant.

The NDA is supported by data from the phase 3 TRIUMpH clinical program and seeks approval for heartburn in NERD, healing of erosive esophagitis, and maintenance of healing.

According to an announcement by parent company Medtronic, the MiniMed Go app is expected to launch in the spring of 2026.

The Q4 recap for cardiology spotlights major FDA decisions, key clinical trial updates, and more.

The Q4 recap for cardiology spotlights major FDA decisions, key clinical trial updates, and more.

The FDA has not approved the sNDA for tasimelteon in jet lag disorder in its current form, citing positive efficacy but limited real-world applicability.

Quarter 4 2025 showed robust advancements in the nephrology field, including FDA news, trial updates, and featured content.

The Q4 recap for endocrinology spotlights major FDA decisions, updates to diabetes care standards, and key clinical trial updates.

This updated approval builds on the success of Fibryga’s 2024 approval for AFD, which was based on positive data from the phase 3 FIBRES trial.

The FDA grants priority review of Vera Therapeutics’s Biologics License Application for the B-cell modulating, atacicept, in IgAN.

Alixorexton receives FDA Breakthrough Therapy Designation, promising significant advancements in treating narcolepsy type 1.

Catch up with major FDA decisions, critical conference news, and more.

Data from the ongoing phase 4 PETITE-T1D study, highlighting the substantially reduced progression to stage 3 T1D, headline the application.

The designation follows positive phase 2b data and FDA alignment on a phase 3 trial.

The decision expands upon caplacizumab’s 2019 approval for adults with acquired thrombotic thrombocytopenic purpura.

The NDA is based on positive 52-week data from the phase 3 VERIFY clinical trial, which demonstrated rusfertide’s capacity to reduce phlebotomy dependency.

Catch up with major FDA decisions, critical conference news, and more.

Catch up on the most impactful headlines in dyslipidemia from all of 2025 with our Year in Review.