USFDA declines to approve Merck chronic cough drug Gefapixant Ruchika Sharma21 Dec 2023 11:30 AM ISTNew Jersey: The U.S. Food and Drug Administration (FDA) declined to approve Merck's drug for chronic cough, the company said on Wednesday,...
USFDA issues EIR for Aurobindo Pharma arm AP facility Ruchika Sharma20 Dec 2023 3:41 PM ISTHyderabad: Aurobindo Pharma has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR)...
Roche Xolair gets USFDA priority review for children, adults with food allergies Ruchika Sharma20 Dec 2023 12:41 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental...
Zydus Lifesciences gets USFDA nod to begin Phase II clinical trial of ZYIL1 in Parkinson's disease patients Ruchika Sharma18 Dec 2023 12:30 PM ISTZydus has been granted an 'Orphan Drug Designation' by the US FDA for ZYIL1 in treatment of patients with CAPS, a rare auto-inflammatory disease.
Lupin, Sun Pharma recall rheumatoid arthritis, thyroid drugs in US Ruchika Sharma18 Dec 2023 11:45 AM ISTNew Delhi: Leading drugmakers Sun Pharma and Lupin are recalling products in the US market over manufacturing issues, as per the US Food and Drug...
Lupin bags USFDA nod for Allopurinol Tablets Ruchika Sharma16 Dec 2023 1:30 PM ISTThe product will be manufactured at Lupin's Pithampur facility in India.
Seizure drug: Zydus Lifesciences gets USFDA approval for Lacosamide tablets Ruchika Sharma16 Dec 2023 12:45 PM ISTThe product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.
Granules Pharma facility gets 5 USFDA observations Ruchika Sharma16 Dec 2023 12:14 PM ISTHyderabad: Granules India Limited has announced that the United States Food and Drug Administration (USFDA) has concluded a GMP inspection...
USFDA gives tentative nod for Lupin diabetes drug Sitagliptin Ruchika Sharma16 Dec 2023 11:30 AM ISTSitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2...
Zydus Lifesciences bags USFDA nod for HIV-1 drug Darunavir Ruchika Sharma15 Dec 2023 3:00 PM ISTDarunavir must be -co-administered with Ritonavir and with other antiretroviral agents.
Merck Welireg gets USFDA approval for kidney cancer Ruchika Sharma15 Dec 2023 12:30 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved...
USFDA nod to Zydus Lifesciences cancer drug Cyclophosphamide Ruchika Sharma14 Dec 2023 3:24 PM ISTCyclophosphamide is a chemotherapy medication that slows the growth of cancer cells.
