FIRST: Roche wins DCGI nod for Atezolizumab to treat small-cell lung cancer Medical Dialogues Bureau22 Nov 2019 6:55 AM GMT"Atezolizumab is the first cancer immunotherapy to receive approval from DCGI in India for the first-line treatment of extensive-stage small-cell lung...
With questions about safety of Meril's Made in India BVS stent, NPPA defers its appeal for price exemption Medical Dialogues Bureau21 Nov 2019 6:39 AM GMTNew Delhi: With an industry association raising health and safety concerns about the flagship Sirolimus-Eluting BioResorbable vascular scaffold system...
Dr Reddys gets CDSCO Committee recommendation for approval for additional indications of Desosumab Farhat Nasim26 Oct 2019 9:08 AM GMTRecently, the Hyderabad-based Dr Reddy's Labs presented its proposal before the CDSCO Committee for an additional indication for Denosumab 120...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 10:40 AM GMT"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...
AstraZeneca India bags DCGI marketing nod for QTERN-once-daily anti-diabetes drug Medical Dialogues Bureau27 Sep 2019 6:24 AM GMT26 September 2019: AstraZeneca Pharma India Limited (AstraZeneca India) announced that it has received Import & Market permission for QTERN®...
CDSCO warns against Cancer Causing Impurities in anti-acidity drug Ranitidine, writes to state drug controllers Farhat Nasim25 Sep 2019 7:49 AM GMTNew Delhi: To ensure patient safety, the country's apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) has ordered an...
Meril Life Sciences gets European Conformity mark for Bioresorbable Scaffold MeRes100 Medical Dialogues Bureau9 Aug 2019 4:15 AM GMTMeril Life Sciences MeRes100 has received both Drug Controller General of India(DCGI) and CE (European Conformity) marketing approval. New Delhi:...
Six bodies registered with CDSCO to audit medical device manufacturing sites as per new MD Rules Farhat Nasim4 Aug 2019 9:59 AM GMTNew Delhi: Through a recent public notice, the apex drug regulatory body, Central Drugs Standard Control Organisation(CDSCO) has notified six bodies...
Torrent Pharma, Glenmark enter agreement to market Remogliflozin under trademark Zucator in India Medical Dialogues Bureau11 July 2019 4:30 AM GMT"Glenmark will manufacture and supply Remogliflozin while Torrent will market the drug under its own trademark 'Zucator' in India," Glenmark Pharma...
Procedure for approval of FDC drugs: CDSCO releases notification; Details Meghna A Singhania24 May 2019 12:42 PM GMTNew Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has directed drug manufacturers and all the...
Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details Meghna A Singhania21 May 2019 11:14 AM GMTNew Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared more than a dozen drugs as sub-standard in...
Adverse Reactions: Cefotaxime, Oflaxicin, Cefixime told to carry Warning by CDSCO Meghna A Singhania17 April 2019 6:56 AM GMTNew Delhi: The national regulatory body for Indian Pharmaceutical and Medical Device, Central Drugs Standard Control Organisation (CDSCO) has ordered...