Action taken against 694 manufacturing units since 2022: Minister Ruchika Sharma25 July 2025 2:30 PM ISTNew Delhi: Actions have been taken against 694 drug manufacturing units following the inspections at 905 firm units since 2022, the...
J&J Imbruvica gains EU approval for untreated Mantle Cell Lymphoma in transplant eligible patients Ruchika Sharma25 July 2025 12:40 PM ISTBeerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the European Commission (EC) has approved an...
Shilpa Medicare arm to infuse USD 2 million in Alveolus Bio Ruchika Sharma25 July 2025 12:13 PM ISTRaichur: Shilpa Medicare has announced that Shilpa Pharma Inc, a wholly owned subsidiary of the company, will make a strategic...
CDSCO Panel Approves Phase IV Protocol Amendment for Bristol-Myers Squibb's Mavacamten Study Parthika Patel24 July 2025 6:49 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has...
Natco Pharma Mekaguda API unit gets USFDA EIR Ruchika Sharma24 July 2025 3:46 PM ISTHyderabad: NATCO Pharma Limited has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection...
Zydus Lifesciences receives tentative approval from USFDA for Chronic lymphocytic leukaemia drug Ibrutinib Ruchika Sharma24 July 2025 3:24 PM ISTAhmedabad: Zydus Lifesciences Limited has announced that it has received tentative approval from the United States Food and Drug Administration...
Roche Itovebi gets European Commission nod in fight against advanced breast cancer Ruchika Sharma24 July 2025 2:30 PM ISTBasel: Roche has received approval from the European Commission for Itovebi (inavolisib), in combination with palbociclib (Ibrance) and...
USFDA extends review period for GSK Blenrep in relapsed/refractory multiple myeloma Ruchika Sharma24 July 2025 1:30 PM ISTLondon: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics License Application...
JnJ Darzalex gets European Commission nod for high-risk smouldering multiple myeloma Ruchika Sharma24 July 2025 12:15 PM ISTBeerse: Janssen-Cilag International NV, a Johnson & Johnson company, has received approval from the European Commission (EC) for a new...
Lupin wins USFDA nods for Liraglutide, Glucagon Injectable Products Ruchika Sharma24 July 2025 11:14 AM ISTMumbai: Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated...
Indoco Remedies gets Certificate of EU GMP Compliance for Goa sterile drug product manufacturing facility Ruchika Sharma24 July 2025 10:15 AM ISTMumbai: Indoco Remedies Limited has received Certificate for EU Good Manufacturing Practices (GMP) Compliance from the European Health...
Eris Gets CDSCO Panel Nod To Dapagliflozin-Bisoprolol-Sacubitril Valsartan Combo Kit, Phase IV Trial Mandated Parthika Patel23 July 2025 7:41 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has...
