Medscape

Pediatric Plaque Psoriasis Treatment Set to Expand in Europe

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.
CIDRAP

Moderna’s combo flu-COVID vaccine receives European authorization

The world’s first combination seasonal influenza and COVID-19 vaccine, Moderna’s mCombriax, has received marketing ...
Zacks Investment Research on MSN

NVS SMA drug gets CHMP backing, malaria drug wins WHO prequalification

Novartis NVS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...
JD Supra

EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept)

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) ...
Healio

EMA stalls B-VEC marketing authorization for dystrophic epidermolysis bullosa

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 ...

Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

COMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth ...
Healio

European Commission grants marketing authorization to Akantior for Acanthamoeba keratitis

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 ...
Benzinga.com

3PTCT : European Commission Declines To Renew Marketing Authorization...

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, ...
TMCnet

Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess® for Vascular Trauma Repair

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

EU Grants Marketing Authorization For KOSTAIVE To CSL And Arcturus Therapeutics

(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

Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki™ (AVT04), the First Biosimilar of Stelara® (ustekinumab)

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) -- ...
Morningstar

Advicenne Has Successfully Renewed the Marketing Authorization of Sibnayal® in European Union

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 ...