Starting this autumn, adults aged 50 and older across the European Union may be able to roll up their sleeve just once and ...

European regulators have recommended expanding use of the IL-23 inhibitor Skyrizi to treat moderate-to-severe plaque psoriasis in children aged 6 years or older who require systemic therapy.

Key market opportunities lie in optimizing regulatory procedures for EU variation submissions, enhancing understanding of Module 3 impacts, and leveraging industry strategies for faster approval in a ...

On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) ...

Please provide your email address to receive an email when new articles are posted on . Krystal Biotech submitted a marketing authorization application to the European Medicines Agency for dystrophic ...

COMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized productmCOMBRIAX will be made available in the European Union, ...

The European Commission (EC) adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) not to renew the authorization of PTC Therapeutics, ...

Please provide your email address to receive an email when new articles are posted on . The authorization is supported by positive data from a phase 3 pivotal trial. Avanzanite Bioscience has ...

Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases ...

(RTTNews) - Biotechnology firm CSL Ltd. (CSL.AX, CMXHF.PK) and sa-mRNA pioneer Arcturus Therapeutics Ltd. (ARCT) announced Friday that the European Commission has granted marketing authorization for ...

(Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that its Marketing Authorization ...

PrJamtekiTM is the second biosimilar developed under this partnership that receives marketing authorization in Canada. REYKJAVIK, Iceland and BOUCHERVILLE, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- ...