Sun Pharma, Zydus recall products in US over manufacturing issues Written By Ruchika Sharma17 March 2025 2:30 PM ISTNew Delhi: Zydus Pharmaceuticals and Sun Pharma are recalling products in the US market due to manufacturing-related concerns, the US health...
USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea Written By Ruchika Sharma17 March 2025 12:45 PM ISTAhmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture ...
Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine Written By Ruchika Sharma17 March 2025 11:30 AM ISTMumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration...
AstraZeneca Imfinzi approved in EU for limited stage small cell lung cancer Written By Ruchika Sharma17 March 2025 10:30 AM ISTThe safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine.
CDSCO Panel Approves Updated Package Insert for Novartis' Ofatumumab Injection Written By 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 Written By 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 Written By 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 Written By 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 Written By 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 Written By 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 Written By 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...
