Lupin secures USFDA okay for Prasugrel tablets used in heart ailments Ruchika Sharma11 Jan 2023 12:06 PM ISTMumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA)...
Zydus Lifesciences bags USFDA nod for Febuxostat Tablets to treat high uric acid Ruchika Sharma11 Jan 2023 11:47 AM ISTAhmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug...
Lupin bags USFDA approval for Fesoterodine Fumarate ER Tablets Ruchika Sharma10 Jan 2023 3:22 PM ISTMumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (USFDA) for...
Biocon Biologics gets complete response letter from USFDA for proposed biosimilar Insulin-R Ruchika Sharma9 Jan 2023 12:15 PM ISTBangalore: Biopharmaceutical company Biocon has announced that the US health regulator has issued a complete response letter for Biocon...
Pfizer 20-Valent Pneumococcal Conjugate Vaccine for infants, children accepted by USFDA for Priority Review Ruchika Sharma8 Jan 2023 4:15 PM ISTNew York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics...
Roche gets USFDA priority review for Glofitamab to treat relapsed or refractory large B-cell lymphoma Ruchika Sharma7 Jan 2023 2:30 PM ISTGlofitamab is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface...
USFDA accepts AstraZeneca’s BLA for Nirsevimab for prevention of RSV lower respiratory tract disease Ruchika Sharma7 Jan 2023 10:00 AM ISTRSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention.
Alembic Pharma bags USFDA nod for Fesoterodine Fumarate ER Tablets to treat overactive bladder Ruchika Sharma6 Jan 2023 12:30 PM ISTVadodara: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA)...
Gland Pharma gets UFSDA EIR for Dundigal Facility Ruchika Sharma5 Jan 2023 2:30 PM ISTHyderabad: Gland Pharma has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices...
USFDA grants appeal for Ardelyx XPHOZAH Ruchika Sharma1 Jan 2023 3:30 PM ISTXPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI).
MediWound bags USFDA nod for NexoBrid to treat severe thermal burns in adults Ruchika Sharma1 Jan 2023 1:00 PM ISTNexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns
Pfizer Pentavalent Meningococcal Vaccine under USFDA review Ruchika Sharma31 Dec 2022 10:00 AM ISTPfizer’s MenABCWY vaccine candidate combines the components of two vaccines into one, helping protect against the meningococcal serogroups that cause...
