CDSCO Panel Approves Updated Package Insert for Novartis' Ofatumumab Injection Dr. Divya Colin16 March 2025 5:45 PM ISTNew Delhi:The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the proposal...
No Long-Term Safety Data: CDSCO Panel Denies Novo Nordisk's proposal to amend warning statement of Semaglutide Dr. Divya Colin16 March 2025 5:15 PM ISTNew Delhi: Citing that there is no real world long-term safety data for Novo Nordisk's antidiabetic drug Semaglutide tablets (3 mg, 7 mg, 14 mg), the...
DoP organises Industry dialogue on PRIP Scheme in Mumbai Ruchika Sharma16 March 2025 11:45 AM ISTNew Delhi: The Department of Pharmaceuticals, Government of India, organised an Industry dialogue on the Promotion of Research and Innovation in...
Bristol Myers Squibb gets European Commission nod for Breyanzi for follicular lymphoma Ruchika Sharma16 March 2025 10:00 AM ISTPrinceton: Bristol Myers Squibb has announced that the European Commission (EC) has granted approval to Breyanzi (lisocabtagene...
Conduct BE study or present safety data: CDSCO Panel tells IQVIA on anti-cancer Drug Daratumumab study Dr. Divya Colin15 March 2025 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined IQVIA to conduct the...
USFDA concludes inspection at Shilpa Medicare Raichur unit Ruchika Sharma15 March 2025 3:50 PM ISTKarnataka: Shilpa Medicare has announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at...
USFDA inspection: Alkem Labs concludes inspection at Taloja Center Ruchika Sharma15 March 2025 3:24 PM ISTMumbai: Alkem Labs has announced the completion of the inspection at the Company's Bioequivalence Center located at Taloja, Maharashtra.The...
JB Chemicals and Pharma Panoli facility concludes USFDA inspection no observations Ruchika Sharma15 March 2025 1:30 PM ISTMumbai: JB Chemicals and Pharma has announced that the Company's API manufacturing facility- D9 located at Plot No. 5, GIDC, Panoli, Gujarat has...
USFDA concludes inspection at Zydus Lifesciences Ankleshwar facility Ruchika Sharma15 March 2025 11:30 AM ISTAhmedabad: Zydus Lifesciences has announced that the US Food and Drug Administration (USFDA) has concluded a surveillance inspection...
1471 drugs samples manufactured in HP failed quality tests in past two years: Minister Ruchika Sharma14 March 2025 5:30 PM ISTShimla: A total of 1,471 drugs samples manufactured in Himachal Pradesh have failed quality tests over the past two years till February 25, 2025,...
Modify Phase III CT protocol: CDSCO panel Tells Windlas Biotech on FDC Tamsulosin plus Mirabegron Dr. Divya Colin14 March 2025 4:00 PM ISTNew Delhi: Responding to the revised Phase III clinical trial protocol of fixed dose combination (FDC) Tamsulosin plus MirabegronIP 0.4 mg/0.4 mg +...
Synokem Pharmaceutical Gets CDSCO Panel Nod To Study Anti-rheumatoid drug Iguratimod Dr. Divya Colin14 March 2025 4:00 PM ISTNew Delhi: Suggesting to specify the eGFR (Modification of Diet in Renal Disease Formula) or chronic kidney disease (CKD) stage in the exclusion...
