Fda

Acuitive Technologies Inc. announced FDA 510(k) clearance for Citrepore, a synthetic bioactive bone void filler designed to promote bone healing after orthopedic surgical procedures, according to a company press release.

The FDA has cleared an investigational new drug application for an epigenetic regulator to treat intractable pain due to idiopathic small fiber neuropathy, according to the manufacturer.

The FDA granted accelerated approval to zanidatamab-hrii for treatment of adults with previously treated unresectable or metastatic HER2-positive biliary tract cancer.

The FDA has approved Bimzelx for the treatment of moderate to severe hidradenitis suppurativa in adults, UCB announced in a press release.

The FDA granted rare pediatric disease and fast track designations to gildeuretinol, an investigational oral therapy for the treatment of Stargardt disease, according to a press release from Alkeus Pharmaceuticals.

Two FDA committees overwhelmingly voted to strike down monitoring requirements under a Risk Evaluation and Mitigation Strategy, or REMS, program for clozapine, a medication for individuals with treatment-resistant schizophrenia.

The FDA approved revumenib for the treatment of certain patients with advanced acute leukemia.

The FDA has accepted the resubmitted new drug application for reproxalap, an investigational treatment for dry eye disease, and assigned a Prescription Drug User Fee Act date, according to a press release from Aldeyra Therapeutics.

The FDA has accepted the resubmission of the supplemental biologics license application for Dupixent to treat chronic spontaneous urticaria in adults and children, Regeneron Pharmaceutical and Sanofi announced in a press release.

Corin has received FDA 510(k) clearance of its Icona femoral stem for direct anterior total hip arthroplasty with design considerations for use in the ASC setting, according to a press release.