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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Read More
In this edition of Quick Notes EU, we note a new EMA guidance on treating exposure to chemical agents used as weapons, the UK’s decision to offer Vertex’s gene editing therapy Casgevy via the NHS for treating an inherited blood disorder, approval of Regeneron’s Ordspono antibody for treatment of lymphoma, and of AstraZeneca’s Imfinzi and Lynparza for treatment of endometrial cancer. Read More
Regeneron Pharmaceuticals has confirmed that the FDA will not make a decision on approving its investigational multiple myeloma drug linvoseltamab for at least the next few months, citing problems encountered during the preapproval inspection of a contract manufacturer. Read More
This edition of Quick Notes features a CRL for Lykos Therapeutics NDA for midomafetamine for treating post-traumatic stress disorder and approvals for Amneal’s Crexont, Novartis’ Fabhalta and Citius Pharmaceuticals’ Lymphir. Read More
The FTC has submitted a comment supporting the FDA draft guidance on interchangeable biosimilar drugs saying that the recommendations in the guidance would increase patient access to lower-cost prescription medications. Read More
This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Read More
After a bumpy road to approval, the FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More
In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for multiple myeloma and a clinical hold on a Type 1 diabetes therapy. Read More
This edition of Quick Notes features an additional indication approval for Palforzia, phase 3 trial results for AstraZeneca’s Calquence, warning from FDA for compounded semaglutide and FDA approval of an alopecia treatment. Read More
Immediately after the FDA rejected Novartis’s 2022 citizen petition for the agency to refrain from approving generic versions of its cardiac drug Entresto (sacubitril and valsartan), the company has filed a lawsuit against the FDA for approval of a generic version. Read More