Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

EMA recommends authorization of Teizeild to delay Type 1 diabetes onset

This is the first drug to receive a recommendation for this preventative indication in the European Union

Shilpa Medicare receives initial authorization for Rivaroxaban Orodispersible films from EMA

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

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls

ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis

Venus Remedies secures firstiInternational market authorization for Sugammadex from the Philippines

The approval marks Venus Remedies’ strategic entry into complex generics, expanding its injectable portfolio beyond traditional formulations