Zydus Lifesciences wins USFDA approval for Oxcarbazepine tablets to treat seizure disorders Ruchika Sharma4 July 2023 3:06 PM ISTAhmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug...
Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray Ruchika Sharma4 July 2023 11:35 AM ISTMumbai:Global pharma major, Lupin Limited, has announced that the Company has received approval from the United States Food and Drug Administration...
Granules India completes USFDA audit at Visakhapatnam facility with zero 483 observations Ruchika Sharma3 July 2023 12:30 PM ISTHyderabad: Granules India Limited, a vertically integrated pharmaceutical company, has completed the U.S. Food and Drug Administration’s (US FDA)...
Zydus Lifesciences gets EIR from USFDA for Pharmez facility Ruchika Sharma3 July 2023 11:44 AM ISTAhmedabad: Zydus Lifesciences has recently announced thatthe Company has received the Establishment Inspection Report (EIR) from the United States...
Zydus Lifesciences gets tentative nod from USFDA for Palbociclib tablets Medical Dialogues Bureau1 July 2023 3:14 PM ISTNew Delhi: Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib tablets,...
USFDA uncovers fresh faults at Aurobindo Pharma MD Bureau1 July 2023 10:00 AM ISTUS Food and Drug Administration officials found multiple faults at a plant run by one of India’s biggest drugmakers as the watchdog continues to...
Zydus Lifesciences bags USFDA tentative nod for breast cancer drug Palbociclib Ruchika Sharma29 Jun 2023 11:33 AM ISTAhmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib...
DCGI nod to Akums Perampanel Oral Suspension to treat epilepsy seizures Ruchika Sharma28 Jun 2023 2:30 PM ISTThe newly approved Perampanel Oral Suspension formulation is now available in 100mL bottles, with a strength of 0.5mg/mL.
Pfizer application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec accepted by USFDA Ruchika Sharma28 Jun 2023 12:30 PM ISTNew York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application...
Gland Pharma gets one USFDA observation for Pashamylaram Facility Ruchika Sharma28 Jun 2023 11:15 AM ISTHyderabad: Gland Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded the inspection at the...
USFDA grants fast track designation for GSK Neisseria gonorrhoeae investigational vaccine Ruchika Sharma27 Jun 2023 1:30 PM ISTGonorrhoea is a sexually transmitted infection caused by a bacterium called Neisseria gonorrhoeae.
Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483 Ruchika Sharma26 Jun 2023 11:08 AM ISTMumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company's Dahej...
