Pfizer Emblaveo gets European Commission marketing nod for patients with multidrug-resistant infections and limited treatment options Ruchika Sharma26 April 2024 12:58 PM ISTNew York: Pfizer Inc. has announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO (aztreonam-avibactam) for...
Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension Ruchika Sharma26 April 2024 11:40 AM ISTMumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug...
Eli Lilly Gets CDSCO Panel Nod to Study Lepodisiran Dr. Divya Colin25 April 2024 6:00 PM ISTNew Delhi: The drug major Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Natco Pharma gets USFDA EIR on pharmacovigilance requirements Ruchika Sharma25 April 2024 5:44 PM ISTTelangana: Natco Pharma has informed in a BSE filing that the Company has received the Establishment Inspection Report (EIR) from the US Food and...
Lupin Digital Health's Lyfe Platform gets Class C Medical Device license from CDSCO Ruchika Sharma25 April 2024 4:23 PM ISTMumbai: Lupin Digital Health, India's evidence-based cardiology Digital Therapeutics (DTx) platform, has announced that its Lyfe platform has...
Indian pharma exports increase 10 percent to USD 27.9 billion in FY24 Ruchika Sharma25 April 2024 3:45 PM ISTNew Delhi: In the fiscal year 2023-24, the nation's exports of drugs and pharmaceuticals increased 9.67 per cent year-on-year to USD 27.9...
GSK application for expanded indication of Jemperli plus chemotherapy accepted by USFDA for priority review Ruchika Sharma25 April 2024 12:40 PM ISTLondon: GSK plc has announced the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for...
Novartis radioligand therapy Lutathera gets USFDA nod for pediatric patients with gastroenteropancreatic neuroendocrine tumors Ruchika Sharma25 April 2024 12:14 PM ISTBasel: Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Lutathera (USAN: lutetium Lu 177 dotatate / INN:...
Zydus Lifesciences Gets CDSCO Panel nod to study Bivalent Typhoid and Paratyphoid A Conjugate Vaccine Dr. Divya Colin24 April 2024 5:15 PM ISTNew Delhi: Reviewing the Phase I clinical trial protocol of the vaccine Bivalent Typhoid and Paratyphoid A Conjugate Vaccine, the Subject Expert...
USFDA issues 10 observations for Zydus Lifesciences Jarod facility Ruchika Sharma24 April 2024 4:01 PM ISTAhmedabad: Zydus Lifesciences has informed in a BSE filing that the US Food and Drug Administration (USFDA) has concluded an inspection with...
New Drug Application of Zydus Desidustat tablets by China Medical System Holdings accepted in China Ruchika Sharma24 April 2024 3:02 PM ISTDiscovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia.
Dr Reddy's recalls six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg over sub potency Ruchika Sharma24 April 2024 1:10 PM ISTHyderabad, Princeton: Dr Reddy's Laboratories Ltd. has announced that it is voluntarily recalling six (6) lots of Sapropterin...
