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Results For "European-Medicines-Agency"

207 News Found

USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program
News | July 27, 2022

Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program

Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.


Novavax statement on EMA Nuvaxovid label update related to allergic reaction
News | July 15, 2022

Novavax statement on EMA Nuvaxovid label update related to allergic reaction

Novavax’ clinical development program reported no severe allergic reactions


Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China
News | July 01, 2022

Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China

Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine


Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer
Drug Approval | June 24, 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally


Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood