Janssen seeks expanded USFDA approval for Rybrevant in combination with chemotherapy Ruchika Sharma29 Aug 2023 12:00 PM ISTRaritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental Biologics License ...
Bristol Myers Squibb gets USFDA nod for Reblozyl as first line treatment of Anemia in lower risk MDS Ruchika Sharma29 Aug 2023 11:09 AM ISTReblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.
Glenmark recalls 1200 bottles of generic hypertension drug in US over manufacturing issue Ruchika Sharma28 Aug 2023 4:33 PM ISTNew Jersey: Glenmark Pharmaceuticals is recalling 1,200 bottles of a generic drug, used to treat high blood pressure, in the American market due...
Gland Pharma gets 2 USFDA observations for Pashamylaram Facility Ruchika Sharma28 Aug 2023 2:30 PM ISTTelangana: Gland Pharma has announced that the Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and...
USFDA nod to Gilead Sciences Veklury to treat COVID19 in people with mild to severe hepatic impairment with no dose adjustment Ruchika Sharma27 Aug 2023 2:30 PM ISTFoster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug...
Pfizer gets USFDA priority review for prostate cancer drug Xtandi Ruchika Sharma26 Aug 2023 12:00 PM ISTXTANDI (enzalutamide) is an androgen receptor signaling inhibitor.
Sandoz bags USFDA approval for biosimilar Tyruko for relapsing forms of multiple sclerosis Ruchika Sharma26 Aug 2023 11:00 AM ISTTyruko has the same intravenous dosage form, route of administration, dosing regimen and presentation as the reference medicine.
Lupin bags USFDA okay for idiopathic pulmonary fibrosis drug Pirfenidone Ruchika Sharma25 Aug 2023 2:33 PM ISTThis product will be manufactured at Lupin's Pithampur facility in India.
Gland Pharma receives USFDA EIR for Dundigal Facility Ruchika Sharma24 Aug 2023 4:30 PM ISTHyderabad: Through a recent BSE filing, Gland Pharma has informed that the Company has received an Establishment Inspection Report (EIR) from the US...
USFDA inspection: Ipca Labs Piparia facility gets VAI status Ruchika Sharma24 Aug 2023 3:15 PM ISTMumbai: Ipca Labs has announced that the United States Food and Drug Administration (USFDA) has determined the inspection classification of...
USFDA approves Zydus Lifesciences Zinc Sulfate Injection Ruchika Sharma24 Aug 2023 2:11 PM ISTThe drug will be manufactured at the group's formulation manufacturing facility at Jarod.
USFDA issues EIR for Torrent Pharma Dahej facility Ruchika Sharma24 Aug 2023 1:30 PM ISTAhmedabad: Torrent Pharmaceuticals Limited has announced that the US drug regulator US Food and Drug Administration (US FDA) has issued an...
