Syngene International gets USFDA EIR for Bengaluru GMP manufacturing facilities Ruchika Sharma16 Jun 2025 10:15 AM ISTKarnataka: Syngene International has announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drugs...
Merck Keytruda approved by USFDA for Advanced Head and Neck Cancer Ruchika Sharma15 Jun 2025 2:30 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...
Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived Dr. Divya Colin15 Jun 2025 12:30 PM ISTNew Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central...
USFDA approves expanded indication for AbbVie Mavyret for Acute Hepatitis C Virus Ruchika Sharma15 Jun 2025 12:00 PM ISTNorth Chicago: AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for a label expansion for MAVYRET...
AstraZeneca collaborates with CSPC Pharma focused on AI-enabled research Ruchika Sharma15 Jun 2025 11:00 AM ISTCambridge: AstraZeneca has entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group Limited.Working...
GSK RSV vaccine Arexvy accepted for regulatory review by EMA to expand use in adults 18 years, older Ruchika Sharma15 Jun 2025 10:00 AM ISTLondon: GSK plc has announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use...
Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC Dr. Divya Colin15 Jun 2025 9:30 AM ISTNew Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification Dr. Divya Colin14 Jun 2025 6:19 PM ISTNew Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Accepts Mylan's Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection Dr. Divya Colin14 Jun 2025 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to accept the...
Pune Horror: Pharma sudent killed on way home by unlicensed driver Ruchika Sharma14 Jun 2025 3:04 PM ISTPune:In a tragic incident on Friday afternoon, a 20-year-old D. Pharma student died after being hit by a car driven by an unlicensed man in Pune’s...
Syngene International Bengaluru facility successfully completes USFDA inspection Ruchika Sharma14 Jun 2025 1:00 PM ISTBengaluru: In a BSE filing, Syngene International has informed that the company's facility at Semicon Park, Bengaluru has successfully...
Sun Pharma gets 8 USFDA observations for Halol facility Ruchika Sharma14 Jun 2025 11:05 AM ISTMumbai: Sun Pharmaceutical Industries Limited has announced that US Food and Drugs Administartion (USFDA) has issued eight observations for its Halol...
