Submission status for BIOGEN INC's drug ZURZUVAE (SUPPL-3) with active ingredient ZURANOLONE has changed to 'Approval' on 04/20/2026. Application Category: NDA, Application Number: 217369, Application Classification: Labeling
Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-13) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 04/20/2026. Application Category: BLA, Application Number: 761183, Application Classification:
SC 13D/A - KEYCORP /NEW/ (0000091576) ()
SC 13D/A - ALLIANCEBERNSTEIN HOLDING L.P. (0000825313) (Subject)
For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s approval of Qfitlia is significant for patients wi
For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an incr
For Immediate Release: February 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis). Odactra is an allergen extract immunotherapy
For Immediate Release: February 21, 2025 Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.“The FDA is dedicated to supporting new drug development for rare diseases including very rare metabolic diseases like cerebrotendinous xanthomato
For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Meri
For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Journavx is the first dr
SC 13D/A - CVR ENERGY INC (0001376139) (Subject)
SC 13D/A - INCOME OPPORTUNITY REALTY INVESTORS INC /TX/ (0000949961) (Subject)
SC 13D/A - Arcus Biosciences, Inc. (0001724521) (Subject)
SC 13D - Neuronetics, Inc. (0001227636) (Subject)
SC 13D/A - Better Home & Finance Holding Co (0001835856) (Subject)
SC 13G - OFFICE PROPERTIES INCOME TRUST (0001456772) (Subject)
SC 13D/A - Flora Growth Corp. (0001790169) (Subject)
SC 13D/A - Flora Growth Corp. (0001790169) (Subject)
SC 13D/A - OLD MARKET CAPITAL Corp (0001000045) (Subject)
