Zydus Cadila gets tentative USFDA nod for arthritis drug Apremilast Farhat Nasim18 Nov 2019 11:08 AM ISTThe company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market generic Apremilast tablets in...
Unichem Labs receives US regulatory nod for generic version of Buspar tablets Farhat Nasim18 Nov 2019 10:00 AM ISTUnichem Labs' Buspirone Hydrochloride tablets are a generic version of Bristol-Myers Squibb Company's Buspar tablets in the same strengths.New Delhi:...
Bristol Myers Squibb gets FTC okay for acquiring Celgene Medical Dialogues Bureau18 Nov 2019 9:50 AM IST"The Commission has ordered Bristol Myers Squibb to divest Otezla to preserve BMS's incentive to continue developing its own oral product for treating...
JnJ directed to pay USD 465 million for fueling opioid epidemic via deceptive marketing of painkillers Farhat Nasim18 Nov 2019 9:45 AM ISTNew Delhi: An Oklahoma judge on Friday said Johnson & Johnson must pay that state $465 million for fueling the opioid epidemic through the...
Novartis sets out new strategy to provide medicines to more patients in sub-Saharan Africa Medical Dialogues Bureau18 Nov 2019 9:00 AM ISTNew Delhi: Novartis announced recently a new strategy to broaden patient reach and availability of its portfolio of medicines in sub-Saharan Africa...
NPPA fixes retail price of 12 combo drugs including Aspirin, Atorvastatin, Metformin; Details Farhat Nasim17 Nov 2019 1:08 PM ISTNew Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the...
Mylan Andhra plant gets USFDA warning over Valsartan manufacturing violations Medical Dialogues Bureau17 Nov 2019 10:15 AM ISTThe concerns cited by the agency were based on an inspection conducted from May 27, 2019, to June 5, 2019, which placed a primary focus on the...
Novartis forecast USFDA approved sickle-cell drug Adakveo annual sales to top USD 1 billion Medical Dialogues Bureau17 Nov 2019 10:00 AM ISTNovartis has forecast that the drug's (Adakveo) annual sales will top $1 billion, much of which will likely come from U.S. government payers such as...
Divis Labs gets no USFDA observations for Unit-I Telangana facility Medical Dialogues Bureau17 Nov 2019 9:45 AM IST"This is to inform that the Company's Unit-I facility at Lingojigudem, Bhuvanagiri Yadadri District, Telangana has been inspected by the USFDA,"...
Agile birth control patch Twirla USFDA review delayed by 3 months, shares slide Medical Dialogues Bureau17 Nov 2019 9:25 AM ISTTwirla, a once-weekly contraceptive patch made from a combination of hormones Ethinyl estradiol and levonorgestrel, was backed by a panel of...
BeiGene gets USFDA approval for lymphoma drug Brukinsa Medical Dialogues Bureau17 Nov 2019 9:20 AM ISTBeiGene tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21%...
Expanding use of Amarin heart drug Vascepa unanimously backed by USFDA panel Medical Dialogues Bureau17 Nov 2019 9:15 AM ISTThe USFDA panel voted 16-0 in favour of expanding approval, potentially opening up a multi-billion dollar opportunity for Amarin which has only one...
