Granules India FDA approval for ADHD treatment

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma

Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg

The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA

Alembic Pharmaceuticals gets USFDA tentative approval for OTC

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets

Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy