February 14th 2025
On February 14, 2025, the FDA approved the first rapid-acting biosimilar insulin product called nsulin-aspart-szjj (Merilog).
February 13th 2025
FDA Approves Subcutaneous Vedolizumab for Moderate to Severe UC
September 28th 2023Data from the VISIBLE 1 trial showed more patients receiving subcutaneous vedolizumab achieved clinical remission, mucosal healing, durable clinical response, durable clinical remission, and corticosteroid-free clinical remission compared to those receiving placebo.
FDA Approves Phentolamine Ophthalmic Solution for Pharmacologically-Induced Mydriasis
September 27th 2023According to the approval, the percentage of study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater in the phentolamine ophthalmic solution group than placebo.
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.