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

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months

Gland Pharma receives approval for phytonadione injection emulsion

This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market

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

Laurus Labs invests in Laurus Bio

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

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