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Results For "marketing-authorization"

183 News Found

Merck wins key EU backing to expand use of PAH Drug WINREVAIR
News | December 13, 2025

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states


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


Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial
Clinical Trials | December 09, 2025

Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial

The study met its primary endpoint and all 11 secondary efficacy endpoints


Bayer reports promising results for low-dose pediatric MRI contrast agent
Clinical Trials | December 07, 2025

Bayer reports promising results for low-dose pediatric MRI contrast agent

MRI is particularly valuable in pediatric care due to its non-invasive nature


Senores Pharmaceuticals receives Philippine FDA approval for 10 products
Drug Approval | December 05, 2025

Senores Pharmaceuticals receives Philippine FDA approval for 10 products

Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions


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


Briefs: Zydus, Divi's Laboratories and Relonchem
News | November 17, 2025

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations


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


Marksans Pharma’s UK Arm Relonchem secures MHRA nod for Exemestane 25mg Tablets
News | November 06, 2025

Marksans Pharma’s UK Arm Relonchem secures MHRA nod for Exemestane 25mg Tablets

Exemestane is a key therapeutic used in the treatment of certain types of breast cancer in postmenopausal women