FDA News

The FDA has issued its third CRL to topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

Investigational RNA interference therapy targeting prekallikrein enters accelerated regulatory pathway as phase 2 trial evaluates long-acting prophylaxis for HAE.

The FDA has set a PDUFA date of December 30, 2026.

This FDA approval of secukinumab (Cosentyx) for hidradenitis suppurativa (HS) represents the fourth pediatric indication for the drug.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat in hypertension, but the selective aldosterone synthase inhibitor fell short in a phase 2 obstructive sleep apnea trial.

This FDA News Month in Review provides a round-up of regulatory decisions from February 2026.

The FDA granted Priority Review and accepted a New Drug Application for rusfertide to treat adults with polycythemia vera.

Navepegritide, to be marketed as YUVIWEL, is the only FDA-approved treatment providing continuous CNP exposure over its weekly dosing interval.

The long-acting growth hormone is now indicated for children aged 2.5 years and older with Idiopathic Short Stature, born Small for Gestational Age, or Noonan Syndrome.

The supplemental New Drug Application submission comes as a result of positive phase 3 data from the CORE and CORE2 trials or olezarsen in 2025.

The FDA has approved proprietary desmopressin oral solution formulation ET-600 for the treatment of central diabetes insipidus in children.

Vanda Pharmaceuticals announced the FDA's acceptance of imsidolimab's Biologics License Application for the treatment of GPP.

FDA approves dupilumab for allergic fungal rhinosinusitis, supported by phase 3 LIBERTY-AFRS-AIMS data showing reduced symptoms and corticosteroid or surgery use.

This approval of the Allurion Gastric Balloon System, incorporating the Allurion Smart Capsule, is indicated for weight loss management for those with obesity.

The FDA has granted both designations to TSRA-196, an in vivo gene editing program from Tessera Therapeutics, for the treatment of PiZZ alpha-1 antitrypsin deficiency.

The FDA denied accelerated approval for bitopertin, citing a need for evidence on clinical benefit from the ongoing phase 3 APOLLO trial.

FDA grants Priority Review for Takeda’s oveporexton, an oral orexin agonist for narcolepsy type 1, showing near-normal symptom control in phase 3.

This FDA News Month in Review provides a round-up of regulatory decisions from January 2026.

Hovanesian breaks down the process by which Yuvezzi received FDA approval and discusses the prescription and application of the new drug.

Despite usability concerns cited by the FDA, investigators say dibutepinephrine’s needle-free, portable design could still address gaps in real-world epinephrine use.

AbbVie’s upadacitinib (Rinvoq) has had its regulatory applications submitted to the FDA and the EMA, with the drug being indicated for adults and adolescents with vitiligo.

Catch up with major trial results, key FDA approvals, and more.

Catch up with major FDA decisions, key guidelines updates, and more.

The resubmission follows a prior Complete Response Letter (CRL) that identified chemistry, manufacturing, and control (CMC) issues.