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RSS FeedPosted by Michael Wonder on 21 Feb 2023
Biohaven's taldefgrobep alfa receives FDA fast track designation for spinal muscular atrophy
21 February 2023 - Taldefgrobep alfa, a myostatin-targeting biologic investigational agent, in Phase 3 development to increase muscle mass for ...
Posted by Michael Wonder on 21 Feb 2023
FDA accepts Orasis Pharmaceuticals' new drug application for CSF-1 for the treatment of presbyopia
21 February 2023 - Investigational, novel eye drop candidate was assigned PDUFA goal date of 22 October 2023. ...
Posted by Michael Wonder on 21 Feb 2023
The FDA returns to its bad habits
20 February 2023 - The agency may nix a new treatment for a debilitating orphan disease. ...
Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...
Posted by Michael Wonder on 20 Feb 2023
Astellas provides update on fezolinetant new drug application in US
20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority ...
Posted by Michael Wonder on 19 Feb 2023
Teva announces FDA approval of Austedo XR (deutetrabenazine) extended release tablets, a new once daily formulation of Austedo (deutetrabenazine) tablets
17 February 2023 - New once daily Austedo XR regimen now approved in 6 mg, 12 mg and 24 mg tablet ...
Posted by Michael Wonder on 18 Feb 2023
Pfizer announces positive Talzenna and Xtandi combination data from Phase 3 TALAPRO-2 trial
16 February 2023 - Supplemental new drug application for Talzenna and Xtandi combination granted US FDA priority review. ...
Posted by Michael Wonder on 18 Feb 2023
Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn
17 February 2023 - In the aftermath of the FDA’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another ...
Posted by Michael Wonder on 18 Feb 2023
Travere Therapeutics announces FDA accelerated approval of Filspari (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy
17 February 2023 - Interim results from the ongoing Phase 3 PROTECT head to head trial demonstrated a rapid, sustained and ...
Posted by Michael Wonder on 18 Feb 2023
FDA approves Syfovre (pegcetacoplan injection) as the first and only treatment for geographic atrophy, a leading cause of blindness
17 February 2023 - Approved for all patients with geographic atrophy, with dosing flexibility every 25 to 60 days. ...
Posted by Michael Wonder on 17 Feb 2023
Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
17 February 2023 - Eisai anticipates about 100,000 patients diagnosed will be eligible for the drug by year three of its ...
Posted by Michael Wonder on 17 Feb 2023
US FDA accepts for priority review the supplemental new drug application for Merck’s Prevymis for prophylaxis of cytomegalovirus disease in kidney transplant recipients at high risk
17 February 2023 - FDA also accepts a separate supplemental application to extend prophylaxis with Prevymis to 200 days in ...
Posted by Michael Wonder on 17 Feb 2023
Chiesi Global Rare Diseases announces FDA approval of Lamzede (velmanase alfa-tycv) for alfa mannosidosis
16 February 2023 - First and only enzyme replacement therapy for the treatment of non-central nervous system manifestations of alfa mannosidosis ...
Posted by Michael Wonder on 17 Feb 2023
Iveric Bio announces FDA accepts new drug application and grants priority review for avacincaptad pegol for the treatment of geographic atrophy
16 February 2023 - PDUFA goal date is 19 August 2023. ...
Posted by Michael Wonder on 16 Feb 2023
Stimufend (pegfilgrastim-fpgk) now available in the United States
16 February 2023 - Fresenius Kabi introduces its first biosimilar in the US. ...