Alembic gets FDA final approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications

Glenmark Pharmaceuticals USA to launch Micafungin for injection USP, 50 mg/vial and 100 mg/vial

According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA

Lupin launches Glucagon for Injection USP, 1mg/Vial in US

Glucagon is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus

Zydus receives NOC from Health Canada for ZDS-Varenicline Tablets 0.5 &1 mg

This is the group’s first NoC approval in Canada

Akums launches high-strength Paracetamol oral suspension 500mg/5ml

Akums bridges the long-standing gap between paediatric syrups and conventional tablet formats

Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint

The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME