GSK Nucala wins USFDA approval for two new self-administration options Farhat Nasim9 Jun 2019 10:00 AM ISTNucala is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for...
Pfizer gets USFDA approval for Vyndaqel, Vyndamax to treat amyloidosis cardiomyopathy Farhat Nasim11 May 2019 9:15 AM ISTNew Delhi: Pfizer Inc's subsidiary FoldRx, has recently won U.S. Food and Drug Administration (USFDA) approved for Vyndaqel (tafamidis meglumine) and...
NPPA likely to cap retailer margins of 73 cancer and rare disease drugs: Report Meghna A Singhania21 Feb 2019 3:13 PM ISTHowever, the move is likely to stimulate retailers to spend more as trade margins on drugs that have somehow bypassed the list and the retailers may...
Pfizer says USFDA accepts regulatory submissions for review of tafamidis Medical Dialogues Bureau16 Jan 2019 9:35 AM ISTPfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial...