Sirio secures TGA GMP certification to support strategic growth in Australia

The Ma’anshan site approval covers pastilles, oral liquids, and powders

ZIM Laboratories granted marketing authorization for Tamsulosin + Dutasteride capsules in Australia

Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients

The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.

Sun Pharmaceuticals receives approval for Winlevi in Australia

Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older

Lupin receives approval from TGA Australia for Tiotropium Dry Powder

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia

Inmagene receives USFDA's IND clearance for ox40 antagonist

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients