This article was originally published in The Tan Sheet
Mylan's ANDA for a generic version of Novartis' antifungal Lamisil tablets (terbinafine HCl 250 mg) gains tentative approval by FDA April 15, the firm reports. Lamisil annual sales totaled approximately $655 mil., according to Mylan...
You may also be interested in...
Coronavirus Notebook: New EMA Review To Contextualize Blood Clot Risk From AZ Jab, EU Gets Earlier Access To More Pfizer Vaccines
Denmark has stopped using the AstraZeneca vaccine completely, while the Canadian regulator is not recommending restrictions in any specific populations. Can a new EMA review provide better context to guide the vaccine’s use in different age groups and gender?
Autolus, Scholar Rock, Rocket and Pfizer have managed to convince the European Medicines Agency that their investigational treatments merit a place on the regulator’s priory medicines scheme.
GlaxoSmithKline has discontinued treatment with its ICOS agonist feladilimab in the Phase II INDUCE-3 trial upon the recommendation of the study’s data monitoring committee, another setback for the big pharma’s plans to become a major force in the cancer therapy area.