USFDA adds Eli Lilly diabetes drug Mounjaro to list of drugs facing shortages Ruchika Sharma18 Dec 2022 2:00 PM ISTThe company is expanding its manufacturing capacity for the two drugs through its facility in North Carolina, and doubling it by the end of 2023.
Ferring Pharma bags USFDA approval for Adstiladrin to treat Bladder Cancer Ruchika Sharma17 Dec 2022 3:58 PM ISTAdstiladrin, an intravesical therapy administered every three months, targets the patient's own bladder wall cells to enhance the body's natural...
USFDA issues warning letter to Sun Pharma Halol facility Ruchika Sharma17 Dec 2022 12:30 PM ISTThe Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can...
Jubilant Pharmova gets 8 USFDA obervations for Nanjangud facility Ruchika Sharma15 Dec 2022 3:00 PM ISTNoida: Jubilant Pharmova Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued eight observations...
USFDA grants accelerated approval for Mirati Therapeutics lung cancer drug KRAZATI Ruchika Sharma13 Dec 2022 3:30 PM ISTSan Diego: Mirati Therapeutics, Inc., a targeted oncology company, has announced that the U.S. Food and Drug Administration (USFDA) has granted...
Glenmark Pharma Goa facility gets USFDA warning letter Ruchika Sharma12 Dec 2022 11:33 AM ISTThe US health regulator also pointed out that the company failed to prepare batch production and control records with complete information relating to...
Janssen seeks USFDA nod for Multiple myeloma treatment Talquetamab Ruchika Sharma11 Dec 2022 1:00 PM ISTRaritan, N.J.: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a Biologics License Application...
Roche Alzheimer's disease Cerebrospinal Fluid assays get USFDA clearance Ruchika Sharma11 Dec 2022 12:00 PM ISTThe Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging.
Zydus Lifesciences bags USFDA nod for Silodosin, Pregabalin capsules Ruchika Sharma10 Dec 2022 2:30 PM ISTPregabalin capsules are indicated to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection.
Alembic Pharma gets USFDA EIR for Oncology Injectable Formulation Facility at Panelav Ruchika Sharma10 Dec 2022 11:18 AM ISTVadodara: Drugmaker Alembic Pharma has recently announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drug...
USFDA nod to Alembic Pharma Desonide Cream Ruchika Sharma9 Dec 2022 1:11 PM ISTDesonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of...
USFDA inspection: Sun Pharma Halol facility listed under import alert Ruchika Sharma8 Dec 2022 4:00 PM ISTMumbai: Pharma major, Sun Pharma, has recently announced that the US Food and Drug Administration (USFDA) has listed its Halol facility...
