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...
Strides Pharma clears USFDA inspection of Alathur facility Medical Dialogues Bureau24 Oct 2019 9:45 AM ISTStrides Pharma said in a filing, the company's formulations unit in Alathur was inspected by the US Food and Drug Administration (USFDA) in August...
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...
Single-member NCLT bench to give finality to split verdict over Unimark Remedies resolution Medical Dialogues Bureau24 Oct 2019 9:00 AM ISTThe NCLT had initiated Corporate Insolvency Resolution Process against Unimark Remedies on Apri 13, 2018 admitting the plea of the private sector...
J&J CEO testified Baby Powder was safe 13 days before FDA bombshell Medical Dialogues Bureau23 Oct 2019 1:21 PM IST"There were in fact differences between cornstarch and talc-based baby powder in its feel, in its absorbency," said Gorsky, who has been J&J's CEO...
Syngene reports robust 11% YOY revenue growth in Q2 FY20 Medical Dialogues Bureau23 Oct 2019 12:18 PM ISTBengaluru: Syngene International Limited recently announced its Q2 FY20 results posting quarterly revenue of Rs. 485 Cr, an increase of 11% from the...
Lupin gets USFDA nod for generic equivalent of Depakote ER Tablets to treat epilepsy in US Medical Dialogues Bureau23 Oct 2019 11:38 AM IST"The United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depakote Extended-Release Tablets, 250 mg and 500 mg, of...
AstraZeneca Farxiga approved in US to reduce heart failure risk in Type-2 diabetes Medical Dialogues Bureau23 Oct 2019 9:30 AM ISTFarxiga is also under regulatory review in China with a decision anticipated in the first half of 2020, AstraZeneca said in a release.New Delhi:...
GSK to sell anti-rabies vaccines Rabipur, Encepur to Bavarian Nordic for USD 1.1 billion Medical Dialogues Bureau22 Oct 2019 10:00 AM ISTThe sale of GSK's anti-rabies treatment Rabipur and Encepur, used for the prevention of tick-borne encephalitis, to the Denmark-based biotechnology...
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...
Hyderabad Pharma City Project: KTR seeks Rs 1318 crore assistance from Centre Medical Dialogues Bureau22 Oct 2019 9:45 AM ISTThe minister contended that Hyderabad Pharma City is the "world's largest integrated pharma park" to promote domestic manufacturing of pharmaceuticals...