Fda

The United States Senate Committee on Health, Education, Labor and Pensions voted to advance the nominations of probable new NIH and FDA leaders to the full senate.

  The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release from Atsena Therapeutics.

The FDA has approved an expanded indication of Soliris, an IV-administered monoclonal antibody for patients aged 6 years and older with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive.

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription Drug User Fee Act date of Oct. 23, according to a press release from Sydnexis.

The FDA approved Celltrion’s omalizumab biosimilar, Omlyclo, for the treatment of multiple conditions including asthma and food allergy, according to an agency press release.

Lawmakers grilled Martin Makary, MD, MPH, on transparency, his plans for mifepristone and his stance on the recently cancelled Vaccine Advisory Committee meeting during Thursday’s senate hearing to be the next FDA commissioner.

The FDA has approved neffy 1 mg epinephrine nasal spray for treating anaphylaxis and other type 1 allergic reactions in children aged 4 years and older, according to a press release from ARS Pharma.

  The FDA approved Encelto, an encapsulated cell therapy, for the treatment of macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, according to a press release from Celltrion.

The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according to the manufacturer.