FDA News

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.

The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.

With the acceptance, the FDA has assigned the oral phosphate binder a Prescription Drug User Fee Act target action date of June 29, 2026.

The FDA approval is based on a pair of phase 3 trials, including the larfest and longest safety study of presbyopia eye drops.

The new approval allows for repeat administration of iDose TR, modifying the existing single-administration label.

FDA prioritizes centanafadine's review for ADHD treatment, offering a novel first-in-class NDSRI option for adults, adolescents, and children.

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.