The FDA has approved baricitinib for adolescents aged 12 and older with severe alopecia areata, marking the first systemic oral therapy cleared for this population.
FDA News and Regulatory Updates
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The FDA has approved insulin efsitora alfa-gobe (Onswik) for adults with type 2 diabetes.
FDA updates sotatercept-csrk label with HYPERION data, showing earlier use cuts PAH clinical worsening risk 76% alongside background therapy.
Finerenone wins FDA clearance for type 1 diabetes–related CKD, lowering albuminuria in FINE-ONE and opening a long-awaited treatment path.
The US FDA cleared a novel insulin patch pump that can be used for up to 3 days with an additional 12-hour grace period in persons with diabetes.
The FDA accepted Organon’s MIUDELLA supplemental application, but the proposed change, supporting data, and review timeline remain undisclosed.
FDA awarded DT120 Breakthrough Therapy designation for MDD based on phase 3 data showing rapid, sustained improvement after one 100 μg dose.
Recent FDA actions include updates in HIV, influenza, narcolepsy, type 2 diabetes, and RSV prevention in high-risk children.
FDA approved bictegravir/lenacapavir for adults with suppressed HIV-1 and no known or suspected component resistance.
Tirzepatide gained an FDA cardiovascular indication after SURPASS-CVOT showed noninferiority to dulaglutide in high-risk adults.
FDA expands dolutegravir dispersible tablets to children with HIV-1 weighing at least 2 kg, including eligible term newborns.
FDA authorized Aletta, a robotic venous blood collection device for supervised outpatient use, through the De Novo pathway.
If approved, ecopipam would be the first new therapy indicated for pediatric patients with Tourette syndrome in more than 10 years.
The FDA approved an autoinjector device for lerodalcibep-liga and an updated indication reflecting cardiovascular risk reduction.
FDA acceptance starts review of clesrovimab for second-season RSV prevention in high-risk children younger than 2 years.
The FDA approved oveporexton for narcolepsy type 1 in adults, marking the first orexin receptor agonist targeting the underlying biological cause of narcolepsy.
The FDA has approved mFLUSIVA, Moderna's first mRNA flu vaccine, for adults 50 and older ahead of the 2026-2027 season.
FDA approval of centanafadine could expand ADHD treatment for patients aged 6 years or older, but labeling and pivotal data remain unavailable.
Recent FDA actions include approvals and clearances in lipid management, CRC screening, contraception, vaginitis testing, and Alzheimer psychosis.
The FDA-licensed product is room-temperature-stable, rapidly reconstituted, and intended for adult transfusion when other plasma products are unavailable.
Viatris' new once-weekly patch delivers norelgestromin and ethinyl estradiol, with a Pearl Index of 4.14 in the Phase 3 Luminous Study.
FDA clearance adds a noninvasive AI-based test for elevated pulmonary capillary wedge pressure to the CorVista System diagnostic platform.
HTX-001, an antisense oligonucleotide targeting WISPER lncRNA, received FDA Fast Track designation as HAYA Therapeutics advances the therapy for nHCM.
FDA approves SimpleScreen CRC, Freenome's blood-based colorectal cancer screening test; Abbott to commercialize it in the US this fall.
FDA cleared Roche’s cobas BV/CV assay to detect bacterial vaginosis and Candida vaginitis from a single vaginal swab sample.
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