Novartis Kymriah wins UK backing after initial lymphoma snub Medical Dialogues Bureau3 Feb 2019 10:00 AM IST"Today's positive announcement regarding access to Kymriah treatment in England and Wales was secured as a result of our close working collaboration...
Dr Reddy's gets four observations from USFDA for Andhra plant Medical Dialogues Bureau19 Jan 2019 9:30 AM IST"The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....
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...
Lupin gets USFDA nod for generic schizophrenia drug Medical Dialogues Bureau8 Jan 2019 12:10 PM ISTNew Delhi: Drug maker Lupin Monday said it has received approval from the US health regulator to market Lurasidone Hydrochloride tablets, used in the...
After damaging Reuters report, J&J doubles down on talc safety message Farhat Nasim1 Jan 2019 9:15 AM ISTTo reassure investors and consumers, J&J has tweeted, posted on Facebook, run a series of full-page newspaper ads across the United States,...
Cadila Healthcare arm gets USFDA nod to market Ranitidine injection Medical Dialogues Bureau12 Dec 2018 10:00 AM ISTNEW DELHI: Drug firm Cadila Healthcare on Tuesday said its subsidiary has received approval from the US health regulator to market Ranitidine...
Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution Medical Dialogues Bureau10 Dec 2018 9:15 AM ISTNew Delhi: Drug firm Alembic Pharma on Monday said it has received approval from the US health regulator for Olopatadine Hydrochloride ophthalmic...
Novartis to launch epinephrine-rival to EpiPens Farhat Nasim7 Dec 2018 9:30 AM ISTNew Delhi: Novartis AG said its U.S. unit Sandoz Inc will launch Adamis Pharmaceuticals Corp's emergency allergy shots next year in the United States,...
US FDA to strictly monitor sale of flavoured e-cigarettes Medical Dialogues Bureau10 Nov 2018 3:46 PM ISTThe new policy will apply to flavoured cartridge-style vaping products like Juul that have become popular among youths, not the open tank-style...
Granules gets 2 observation by USFDA for U.S Unit Medical Dialogues Bureau30 Oct 2018 10:48 AM ISTNew Delhi: Pharma firm Granules through a recent regulatory filing announced its US subsidiary has received two observations from the US health...
Hypoglycaemia, Mental Health Side Effects: Label side-effect warnings of Fluoroquinolone, DCGI tells Drugmakers Medical Dialogues Bureau26 Oct 2018 11:04 AM ISTFluoroquinolones are antibiotics used to treat respiratory and urinary tract infections. These medicines include ciprofloxacin, gemifloxacin,...
Sun Pharma and SPARC's XELPROS gets USFDA approval Medical Dialogues Bureau15 Sept 2018 4:32 PM ISTUS Food and Drug Administration (USFDA) has approved the SPARC new drug application of XELPROS, used to reduce glaucoma open-angle glaucoma or ocular...
