ICRA revises domestic pharma industry outlook to negative due to coronavirus outbreak Medical Dialogues Bureau21 Feb 2020 12:22 PM ISTAccording to Icra research, domestic API manufacturers have an inventory of one-two months, which should adequately support their production till...
FDA grants priority review to Roche's Tecentriq monotherapy as first-line treatment in certain lung cancer cases Medical Dialogues Bureau20 Feb 2020 2:20 PM ISTBasel: Roche announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and...
USFDA, Indian Government Join hands to clamp down on Illicit Medical Products Medical Dialogues Bureau19 Feb 2020 12:54 PM ISTUS: The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India stopped...
USFDA completes inspection of Lupin's Aurangabad facility Medical Dialogues Bureau17 Feb 2020 4:18 PM ISTMumbai: Pharma major Lupin Limited (Lupin) announced the completion of the United States Food and Drug Administration (U.S. FDA) inspection carried...
USFDA seeks voluntary action at Dr Reddy's Duvvada facility Medical Dialogues Bureau17 Feb 2020 3:10 PM ISTNew Delhi: The US health regulator has asked drug major Dr Reddy's Laboratories to initiate voluntary action at its Duvvada facility in Andhra...
Granules India gets tentative USFDA nod for generic version of Mucinex ER Tablets Medical Dialogues Bureau15 Feb 2020 11:00 AM ISTNew Delhi: Drugmaker Granules India Limited recently announced that the company has received tentative approval from the US Food & Drug...
Zydus Cadila gets USFDA nod for bowel disease drug Mesalamine suppositories Farhat Nasim13 Feb 2020 1:04 PM IST"Zydus Cadila has received the final approval from the USFDA to market Mesalamine Suppositories for rectal use...1000 mg," the drug firm said in a...
Lupin Pithampur unit gets 2 USFDA observations Medical Dialogues Bureau13 Feb 2020 12:52 PM ISTThe inspection of the company's Pithampur Unit-I facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in...
MEDICREA UNiD IB3D Patient-Matched interbody cages get USFDA clearance Medical Dialogues Bureau13 Feb 2020 10:00 AM ISTNew York: MEDICREA, pioneering the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants...
Novartis cancer therapy MET inhibitor capmatinib granted USFDA priority review Medical Dialogues Bureau13 Feb 2020 9:45 AM ISTCapmatinib (INC280) is an investigational, oral, potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the...
Granules India gets tentative USFDA nod for generic Colchicine capsules Medical Dialogues Bureau12 Feb 2020 2:34 PM ISTNew Delhi: Drug firm Granules India on Tuesday said it has received tentative approval from the US health regulator for its generic Colchicine...
Sun Pharma arm- SPARC application for cancer drug Taclantis rejected by USFDA Medical Dialogues Bureau12 Feb 2020 1:10 PM IST"The company has received a Complete Response Letter (CRL) from the United States Food & Drug Administration (USFDA) for the new drug application...
