Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations Medical Dialogues Bureau2 Nov 2019 9:45 AM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for...
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...
Cadila Healthcare gets EIR from USFDA for Baddi facility Medical Dialogues Bureau1 Nov 2019 2:11 PM ISTNew Delhi: Drug firm Cadila Healthcare on Thursday said its Baddi facility in Himachal Pradesh has received establishment inspection report (EIR) from...
SETBACK: Novartis Zolgensma study halted by USFDA amid safety concerns Medical Dialogues Bureau31 Oct 2019 9:45 AM ISTNovartis shares fell 1% at 0715 GMT, while other European drugmakers rose. Analysts said more information was needed to assess whether these findings...
Biogen, Alkermes get USFDA nod for multiple sclerosis drug Vumerity Medical Dialogues Bureau31 Oct 2019 9:25 AM ISTThe new drug, Vumerity, was approved to treat relapsing forms of multiple sclerosis, a disabling autoimmune disease that damages the central nervous...
IOL Chemicals and Pharma Ibuprofen manufacturing facilities in Barnala clears USFDA inspection Medical Dialogues Bureau30 Oct 2019 2:11 PM ISTMumbai: IOL Chemicals and Pharmaceuticals (IOLCP) recently received a communication from US Food and Drug Administration (USFDA) with respect to an...
New tests shows NO sign of asbestos in recalled JnJ baby powder Medical Dialogues Bureau30 Oct 2019 1:18 PM ISTBut Johnson & Johnson (JnJ) said in a statement that dozens of tests by two outside firms did not detect any asbestos in JnJ's baby powder.New...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 10:00 AM ISTThe audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the...
Alkem Labs Bioeguivalcnce Center at Taloja clears USFDA inspection Medical Dialogues Bureau28 Oct 2019 10:00 AM IST"This is to inform that the US FDA had conducted an inspection at Alkem Laboratories Ltd's Bioequivalence Center located at Taloja, Maharashtra from...
CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug Farhat Nasim27 Oct 2019 11:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker,...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 11:46 AM IST"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Cadila Healthcare arm gets USFDA nod for Haloperidol Decanoate injection to treat schizophrenia Medical Dialogues Bureau25 Oct 2019 11:32 AM ISTHaloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome, Cadila Healthcare...
