FDA News

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.

In December 2025, intervention strategies, dialysis modalities, and kidney transplantation data provided insight to improve renal care for clinicians.

The CRL notes that additional mechanistic and natural history data have not altered the previous review conclusions.

The novel oral NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor has indicated its efficacy and safety across 3 clinical trials.

The FDA has issued a CRL for selective cortisol modulator relacorilant, citing a need for more evidence of effectiveness.

The FDA has approved oral neurokinin-1 receptor antagonist tradipitant for the prevention of motion sickness, marking the first approval in decades.

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

FDA clears first human umbilical cord–derived sheet device, Theracor, for wound Care

The FDA grants breakthrough therapy designation for ulizacaltamine for the treatment of essential tremor.

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

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

The FDA has approved small-molecule pyruvate kinase R activator mitapivat for the treatment of anemia in adults with alpha- or beta-thalassemia.