USFDA concludes inspection at Cipla Qidong facility with zero observations Ruchika Sharma2 March 2024 12:29 PM ISTMumbai: Cipla has announced that the United States Food and Drug Administration (USFDA) has concluded a pre-approval inspection with zero Form 483...
Aurobindo Pharma bags USFDA nod for Fingolimod Capsules for multiple sclerosis Ruchika Sharma2 March 2024 11:32 AM ISTFingolimod Capsules, 0.5 mg, is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical...
USFDA closes inspection at Shilpa Medicare Hyderabad lab Ruchika Sharma1 March 2024 4:52 PM ISTKarnataka: Shilpa Medicare has announced that the United States Food and Drug Administration (USFDA) has closed the inspection at the...
Biocon Biologics secures US market entry date for Bmab 1200, a Proposed Biosimilar to Stelara Ruchika Sharma1 March 2024 3:30 PM ISTStelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has...
Sandoz US subsidiaries resolve generic drug antitrust class action litigation with direct purchaser class plaintiffs Ruchika Sharma1 March 2024 3:03 PM ISTBasel: Sandoz Inc. and its subsidiary Fougera Pharmaceuticals Inc. (together, "Sandoz US") - both indirect subsidiaries of Sandoz Group AG - have...
USFDA issues 7 observations for Aurobindo Pharma arm Telagana injectable facility Ruchika Sharma1 March 2024 2:00 PM ISTTelangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with 7...
Biocon Biologics Biocon Campus (Site 1) facility gets 4 USFDA observations Ruchika Sharma1 March 2024 12:01 PM ISTBangalore: Biocon has recently announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483s with 4 observations at...
Roche Pharma unveils multiple sclerosis treatment drug Ocrevus in India Ruchika Sharma29 Feb 2024 5:00 PM ISTNew Delhi: Roche Pharma India has launched a drug for the treatment of Multiple Sclerosis (MS), expanding its neurology portfolio to cater...
Biological E, Takeda join hands to accelerate access to Dengue Vaccine in endemic areas Ruchika Sharma29 Feb 2024 3:00 PM ISTHyderabad: Takeda and Biological E. Limited (BE), an India-based Vaccines and Pharmaceutical Company, has announced a strategic partnership...
Bayer gets USFDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations Ruchika Sharma29 Feb 2024 1:30 PM ISTBAY 2927088 was derived from Bayer's long-standing strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
Eli Lilly expects to launch diabetes drug Mounjaro in India next year: CEO Ruchika Sharma29 Feb 2024 12:30 PM ISTMounjaro, chemically known as tirzepatide, is currently sold in the UK and Europe under the same brand name for both conditions.
Alkem Labs gets USFDA EIR for Mandva facility Ruchika Sharma29 Feb 2024 11:54 AM ISTMumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the...
