GSK ovarian cancer drug Zejula gets USFDA nod for wider use Medical Dialogues Bureau24 Oct 2019 10:00 AM ISTZejula was the lead compound of U.S. cancer specialist Tesaro, which GSK acquired for $5.1 billion last year. Zejula brought in sales of 57 million...
Dr Reddys recalls Ranitidine products in US over cancer-causing impurity Medical Dialogues Bureau24 Oct 2019 9:30 AM ISTThis recall follows the USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, Dr...
No carcinogen found in alternatives of heart burn drug Zantac, generics: USFDA Medical Dialogues Bureau24 Oct 2019 9:20 AM ISTEarly tests of alternatives to over-the-counter ranitidine, such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec show no NDMA, the agency said.New...
Roche Tecentriq, Avastin combo to increase overall survival, progression-free survival in HCC Medical Dialogues Bureau22 Oct 2019 9:50 AM ISTRoche, in its recent release, in 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in...
Sanofi pulls popular heartburn drug Zantac in US, Canada Medical Dialogues Bureau21 Oct 2019 9:30 AM ISTIn September, the Food and Drug Administration said a potentially cancer-causing chemical had been detected at low levels in prescription and...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...
FIRST: Sun Pharma unveils dry-eye treatment drug CEQUA in US Farhat Nasim14 Oct 2019 1:13 PM ISTNew Delhi: Through a release, drug major, Sun Pharmaceutical Industries Ltd. (Sun Pharma) today announced that one of its wholly-owned subsidiaries...
Cadila Healthcare largest API manufacturing site clears USFDA inspection Medical Dialogues Bureau12 Oct 2019 11:41 AM ISTThe US Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from...
Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 10:00 AM IST"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
Torrent Pharma shares slump 3pc on USFDA warning letter for Gujarat facility Medical Dialogues Bureau11 Oct 2019 9:15 AM ISTTorrent Pharma does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of...
Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol Medical Dialogues Bureau10 Oct 2019 11:34 AM ISTZydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Colesevelam Hydrochloride tablets,...
Galderma wins USFDA nod for AKLIEF Cream to treat acne Medical Dialogues Bureau10 Oct 2019 9:30 AM ISTNew Delhi: Galderma, announced recently that the U.S. Food and Drug Administration (USFDA) has approved AKLIEF (trifarotene) Cream, 0.005% for the...
