Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk

The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk

Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad

Sun Pharma launches Unloxcyt for advanced cutaneous squamous cell carcinoma treatment

UNLOXCYT is an evolution in checkpoint inhibition and is now available for the treatment of adults in the U.S. with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation

EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation

FDA endorses Relmada’s registrational strategy for bladder cancer therapy

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

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

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million

Briefs: Medicamen Biotech and Gland Pharma

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

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation