Drug Approval | April 01, 2025
OneSource Specialty Pharma updates on cGMP inspection by USFDA
The inspection has concluded with four observations
The inspection has concluded with four observations
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region
Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility
New facility will support plans to advance J&J’s portfolio and pipeline of transformational medicines for cancer, immune-mediated and neurological diseases
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m
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