Novartis gets U.S. nod for long-delayed copycat version of Amgen billion seller Neulasta drug Medical Dialogues Bureau6 Nov 2019 10:32 AM ISTZURICH: Novartis on Tuesday won U.S. approval for its long-delayed version of Amgen's $4 billion seller Neulasta drug, helping the Swiss drugmaker in...
Biocon gets EIR from USFDA for Bengaluru biologics unit Medical Dialogues Bureau6 Nov 2019 9:19 AM ISTNew Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its...
Most Serious: USFDA issues Class 1 recall on Abbotts CentriMag blood pumping system Medical Dialogues Bureau5 Nov 2019 1:05 PM ISTThe U.S. Food and Drug Administration on Monday classified the recall of Abbott Laboratories' CentriMag blood pumping system following the death of a...
Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility Medical Dialogues Bureau5 Nov 2019 12:57 PM ISTNew Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation...
Sun Pharma Advanced Research Company Q2 loss widens to Rs 63 cr Medical Dialogues Bureau5 Nov 2019 12:55 PM ISTNew Delhi: Sun Pharma Advanced Research Company (SPARC) on Monday reported a net loss of Rs 63.16 crore for the quarter ended September 30 of the...
Strides Pharma Ranitidine tablets within acceptable NDMA limits, says USFDA Medical Dialogues Bureau4 Nov 2019 4:31 PM ISTNew Delhi: Drug firm, Strides Pharma recently announced that the USFDA issued a statement1 on November 1, 2019, providing an update with the latest...
GSK Benlysta gets European nod for treatment of children with lupus Medical Dialogues Bureau4 Nov 2019 9:15 AM ISTNew Delhi: GlaxoSmithKline (GSK) plc recently announced that the European Commission has adopted a decision to extend to children five years and...
AbbVie says multiple parties vying for assets related to Allergan deal approval Medical Dialogues Bureau4 Nov 2019 9:00 AM ISTAbbVie Inc said it had notified the U.S. antitrust watchdog of its intention to divest its experimental inflammatory bowel disease therapy,...
Another delay in USD 2.1 million gene therapy Zolgensma data reporting, Novartis admits mistake Medical Dialogues Bureau3 Nov 2019 9:45 AM ISTThe USFDA on Wednesday placed a partial hold on a Novartis trial of the $2.1 million-per-patient gene therapy, Zolgensma after the company informed...
Amgen to reduce price of its cholesterol drug Repatha starting 2020 Medical Dialogues Bureau3 Nov 2019 9:15 AM ISTAmgen launched the lower-price option of Repatha last October, selling the drug to some patients under the list price of $5,850 per year because the...
Bristol-Myers Opdivo, Yervoy show promise in lung cancer trial Medical Dialogues Bureau3 Nov 2019 9:00 AM ISTBristol-Myers Squibb said its therapies when administered alongside two courses of chemotherapy demonstrated superior overall survival compared to...
Tests indicate heartburn drug Zantac does not form carcinogen in users: USFDA Medical Dialogues Bureau2 Nov 2019 9:30 AM ISTZantac sold over-the-counter in the United States by French drugmaker Sanofi SA, and some of its generic versions, have been recalled due to possible...
