September 19th 2023
The company shared anticipation that their BLA decision for bimekizumab to treat adults with plaque psoriasis will not come before the end of this month.
CVS, Walgreens Among Companies to Receive FDA Warning for Marketing Unapproved Eye Drops
September 12th 2023On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
FDA Issues CRL for Ophthalmic Bevacizumab in Wet AMD
August 30th 2023Outlook Therapeutics announced receipt of the CRL exactly one year after resubmission of their BLA for ONS-5010 as a treatment for wet age-related macular degeneration, which would have been the first indication for a retinal disease given to an ophthalmic version of bevacizumab.
AbbVie Submits Application to FDA for Risankizumab in Ulcerative Colitis
August 28th 2023AbbVie submitted regulatory applications to the FDA and EMA for rizankizumab 1200 mg intravenous induction dose and 180 mg and 360 mg subcutaneous maintenance dose following successful Phase 3 trials INSPIRE and COMMAND.
Tandem Mobi Insulin Pump, Billed as World's Smallest Insulin Pump, Receives FDA Clearance
July 12th 2023Announced by Tandem Diabetes Care on July 11, 2023, the Tandem Mobi insulin pump is billed as the world's smallest insulin pump, at less than half the size of the t:slim X2 pump and able to fit in a coin pocket.
Roctavian Receives Approval by the FDA for Severe Hemophilia A
June 29th 2023The approval is supported by positive results from the largest and longest phase 3 study for gene therapy in hemophilia, showing a 52% reduction in annualized bleeding rate compared with baseline rates on routine prophylaxis.
Intercept Cancels Plans For NASH Treatment After CRL
The treatment, developed by Intercept Pharmaceuticals, could not be approved in its present form, according to the CRL and any resubmission of the treatment for patients with NASH would require at least the successful completion of the long-term outcomes phase of the REGENERATE study.
FDA Approves Empagliflozin, Empagliflozin plus Metformin for Pediatric Type 2 Diabetes
June 20th 2023The FDA's historic June 20, 2023 approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) marks the first pediatric type 2 diabetes indication for the SGLT2 inhibitor class and comes less than a year after the debut of DINAMO data.