Sanofi Tolebrutinib faces USFDA review delay; new target action date set for December 28 Ruchika Sharma22 Sept 2025 5:09 PM ISTParis: Sanofi has announced that the US Food and Drug Administration (FDA) has extended by three months the target action date of its review of...
CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel Susmita Roy22 Sept 2025 4:48 PM ISTNew Delhi: Noting that there was one death during the trial, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
CDSCO Panel Approves Cipla's Levormeloxifene Study Amendment, Mandates Transvaginal Sonography Susmita Roy22 Sept 2025 4:24 PM ISTNew Delhi: The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has recommended approval for an...
115 hospital pharmacies in Telangana receive show cause notices Ruchika Sharma22 Sept 2025 4:10 PM ISTTelangana: A total of 115 pharmacies located in or attached to various corporate hospitals across Telangana have received show cause notices.The Drugs...
AstraZeneca-Amgen Tezspire recommended for approval in EU for chronic rhinosinusitis with nasal polyps Ruchika Sharma22 Sept 2025 2:00 PM ISTCambridge: AstraZeneca and Amgen's Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for the treatment of adult...
CII, ICON host strategic dialogue on Indian pharma move toward US manufacturing Ruchika Sharma22 Sept 2025 1:00 PM ISTNew Delhi: ICON, a US-based construction company in collaboration with the Confederation of Indian Industry (CII ) Telangana, has successfully...
Medicines worth Rs 50000 seized from quack clinic in Telangana Ruchika Sharma22 Sept 2025 12:00 PM ISTTelangana: The Drugs Control Administration, Telangana, has uncovered a case of illegal drug stocking following a raid at a quack's clinic in Nagaram...
Jubilant Pharma arm completes USFDA inspection with zero observations Ruchika Sharma22 Sept 2025 11:01 AM ISTNoida: Jubilant Pharmova Limited has announced the completion of the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug...
Zydus gets USFDA EIR for Ahmedabad oncology injectable manufacturing facility Ruchika Sharma22 Sept 2025 10:51 AM ISTAhmedabad: Zydus has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for a GMP follow-up...
Merck receives positive EU CHMP opinion for Enflonsia for RSV in infants Ruchika Sharma21 Sept 2025 4:15 PM ISTRahway: Merck, known as MSD outside of the United States and Canada,,has announced that the Committee for Medicinal Products for Human Use (CHMP) of...
Chennai Pharma Firm Under ED Net in Rs 637 Crore Bank Fraud Case Parthika Patel21 Sept 2025 4:00 PM ISTChennai: The Enforcement Directorate (ED) has launched multi-state raids across Tamil Nadu, West Bengal, and Goa, targeting Chennai-based...
Biocon Gets CDSCO Panel Nod to Import Aflibercept Injection for Eye Disorders, Phase IV Trial Mandated Parthika Patel21 Sept 2025 3:30 PM ISTNew Delhi: Biocon Biologics Limited has received recommendations from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
