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

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older

UK Relonchem receives marketing authorization for Levonorgestrel 1.5 mg Tablets

Relonchem Limited has received Marketing Authorization for the product Levonorgestrel 1.5 mg Tablets from UK MHRA