Unexo Lifesciences Faces USFDA Heat Over Serious CGMP Violations Farhat Nasim22 Nov 2024 2:13 PM ISTIn response to the issues, the USFDA recommended a voluntary recall of all drug products manufactured at Unexo's facility for the U.S. market.
Wockhardt Founder Seeks GST Exemption on India-Discovered Antibiotics to Enhance Affordability Farhat Nasim22 Nov 2024 1:19 PM ISTAt an event celebrating India's first indigenously developed antibiotic, Nafithromycin, Khorakiwala highlighted the disparity in GST.
Jazz Pharma's Ziihera Gets USFDA Nod To Treat HER2-Positive Biliary Tract Cancer Farhat Nasim22 Nov 2024 12:30 PM ISTThe drug zanidatamab-hrii, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary...
Pfizer's HYMPAVZI gets European Commission Approval to Treat Severe Hemophilia A and B Farhat Nasim21 Nov 2024 3:26 PM ISTDelhi: Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab) for the routine...
Strides Pharma Secures NCLT Approval for OneSource, India's First Specialty Pharma CDMO Farhat Nasim21 Nov 2024 1:56 PM ISTMumbai: Strides Pharma Science Limited, on Tuesday, announced that the National Company Law Tribunal (NCLT), Mumbai Bench, has approved its Scheme of...
Cipla Recalls Lanthanum Carbonate Tablets in US Farhat Nasim21 Nov 2024 1:38 PM ISTAs per the USFDA, New Jersey based Cipla USA, Inc is recalling the affected lot due to "complaints received of crushed and broken tablets".
Hyderabad Pharma Plant Explosion Leaves 1 Dead, 3 Injured Farhat Nasim21 Nov 2024 1:24 PM ISTHyderabad: In an unfortunate incident, a chemical reactor explosion at Aurore Pharmaceuticals Private Ltd in Hyderabad claimed life of a worker, while...
Sage Therapeutics' Experimental Drug for Huntington's Disease Fails Mid-Stage Trial Farhat Nasim21 Nov 2024 11:30 AM ISTThe drug, dalzanemdor, did not significantly improve cognitive function in patients compared to placebo after 84 days, failing to meet the main goal
Lupin's generic drug to treat ADHD symptoms gets USFDA approval Farhat Nasim20 Nov 2024 2:57 PM ISTMumbai: Lupin Limited announced on Tuesday that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its...
Merck's Injectable Keytruda Proves Effective in Trial, Promises Easier Cancer Treatment Farhat Nasim20 Nov 2024 2:01 PM ISTMerck was testing the injectable version of the world's biggest selling drug in a late stage trial of patients with a type of lung cancer.
USFDA Inspection: Dr Reddy's gets Form 483 with 7 observations for Bollaram facility Farhat Nasim20 Nov 2024 1:48 PM ISTNew Delhi: Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active...
Novo Nordisk Enters China's Obesity Market with Wegovy Launch, Eyes 180 Million Patients Farhat Nasim20 Nov 2024 1:36 PM ISTThe move intensifies the competition with Eli Lilly, which secured approval for its weight loss drug in China in July but has yet to launch it.
