Horizon thyroid eye disease drug Tepezza priced at USD 14900 per vial Medical Dialogues Bureau22 Jan 2020 10:06 AM IST Horizon said the drug, Tepezza will earn about $105 million in milestone payments in the first half of 2020. The company last week raised its...
Biocon Bengaluru facility clears USFDA inspection Farhat Nasim21 Jan 2020 1:00 PM IST The US Food and Drug Administration (USFDA) conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, a...
Alembic Pharma gets two USFDA observations for Karkhadi facility Medical Dialogues Bureau21 Jan 2020 12:50 PM ISTNew Delhi: Drugs maker, Alembic Pharma recently announced that the company's API facility located at Karkhadi has received Form 483 with two...
Strides Pharma arm gets EIR from USFDA for Florida facility Medical Dialogues Bureau21 Jan 2020 11:28 AM IST The Florida facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations...
Cipla Patalganga facility gets EIR from USFDA Farhat Nasim20 Jan 2020 11:52 AM IST "Following the inspection by the United States Food and Drug Administration (USFDA) at the Patalganga manufacturing facility of the company from...
Lupin gets 5 USFDA observations for Vizag facility Medical Dialogues Bureau20 Jan 2020 11:24 AM IST The inspection for the API facility at Vizag closed with five 483 observations, Lupin said. New Delhi: Drug firm Lupin on Saturday said it has...
Alembic Pharma gets USFDA nod for spasticity drug Tizanidine MD bureau15 Jan 2020 10:15 AM ISTNew Delhi: Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride...
USFDA panel votes against Nektar painkiller MD bureau15 Jan 2020 9:00 AM ISTNew Delhi: Independent advisers to the U.S. Food and Drug Administration on Tuesday unanimously voted against Nektar Therapeutics' opioid painkiller...
Lupin gets 2 observations from USFDA for Nagpur facility Medical Dialogues Bureau13 Jan 2020 11:58 AM ISTDrug firm Lupin on Saturday said it has received two observations from the US health regulator following the inspection of its Nagpur manufacturing...
Abbott gets USFDA nod for less-invasive surgical approach for heart pump Medical Dialogues Bureau9 Jan 2020 3:32 PM ISTNew Delhi: Abbott recently announced U.S. Food and Drug Administration (USFDA) approval of a new alternative surgical technique for Abbott's HeartMate...
FIRST: Mylan, Micro Labs get USFDA nod for generic version of blood thinner Eliquis Medical Dialogues Bureau24 Dec 2019 9:45 AM ISTSales of Eliquis, which Bristol-Myers co-developed with Pfizer, rose 22% to $1.93 billion and made up about 30% of the Bristol-Myers' total revenues...
MTaI to work closely with DoP, Invest India to promote investments in medical device sector Medical Dialogues Bureau30 Nov 2019 12:42 PM IST"MTaI has been engaging with the Department of Pharmaceuticals and the Invest India team closely to work on several corrective measures which will...
