FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations

MHRA warns of extremely rare vision risk linked to semaglutide

Semaglutide—a glucagon?like peptide?1 receptor agonist (GLP-1RA) sold as Ozempic and Rybelsus for type 2 diabetes, and Wegovy for weight management and cardiovascular risk reduction

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa

Akums bags key EU GMP certifications for 2 Haridwar plants

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms

Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is an antihistamine eye drop, indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander

FDA nod to first-ever treatment for fatal pediatric Menkes disease

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

UK’s healthcare regulator warns against dangerous online weight-loss drugs

Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,