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Results For "authorization"

359 News Found

Venus Remedies gets marketing authorization for Ceftriaxone in Argentina
Drug Approval | May 07, 2026

Venus Remedies gets marketing authorization for Ceftriaxone in Argentina

Approval strengthens the company’s growing international anti-infective portfolio


EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control
Medical Device | April 28, 2026

EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

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
News | November 23, 2025

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
Drug Approval | November 17, 2025

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


ZIM Laboratories granted marketing authorization for Tamsulosin + Dutasteride capsules in Australia
News | August 08, 2025

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
News | July 27, 2025

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
Clinical Trials | July 08, 2025

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
News | June 26, 2025

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