FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states

Grace and Molecule.one strike multi-year AI pact to break peptide manufacturing bottlenecks

These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA