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Results For "marketing-authorization"

190 News Found

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


Evofem's SOLOSEC submitted for regulatory approval in the UAE
News | October 06, 2025

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment