European Vaccines Hub for Pandemic Readiness Launches
On May 23, 2025, The Health Emergency Preparedness and Response Authority (HERA) of the European Commission, through the…
EC Approved Pfizer’s HYMPAVZI™ (marstacimab) for Treatment of Adults and Adolescents with Severe Hemophilia
On Nov, 20, 2024, Pfizer announced that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab)…
Novavax’s Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Received Authorization in the EU
On Oct. 9, 2024, Novavax announced that the European Commission had granted Marketing Authorization for Novavax’s updated 2024-2025…
European Commission Approved Pfizer’s DURVEQTIX® (fidanacogene elaparvovec), a One-Time Gene Therapy for Adults with Hemophilia B
On Jul. 25, 2024, Pfizer announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX®…
Dupixent® (dupilumab) Approved in the European Union as the First-ever Targeted Therapy for Patients with COPD
On Jul. 3, 2024, Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) has approved Dupixent® (dupilumab)…
CSL Seqirus Signed an Agreement with the European Commission to Provide Pre-Pandemic Vaccines to the EU
On Jun. 11, 2024, CSL Seqirus was selected by the Health Emergency Preparedness and Response Authority (HERA), part…
Biogen received European Commission approval for QALSODY® (tofersen), first therapy for rare, genetic form of ALS
On May 30, 2024, Biogen announced that the European Commission (EC) had granted marketing authorization under exceptional circumstances…
European Commission approved first CRISPR/Cas9 gene-edited therapy, CASGEVY for reatment of SCD and TDT
On Feb. 13, 2024, CRISPR Therapeutics announced that the European Commission had granted conditional marketing authorization to CASGEVY…
Biotechnology | Disease | FDA | Therapeutics
Swissmedic Authorises CSL’s HEMGENIX® (etranacogene dezaparvovec) as First Gene Therapy for Hemophilia B
On Jan. 15, 2024, CSL announced that Swissmedic had authorised HEMGENIX® (etranacogene dezaparvovec), the first and currently only gene…
Biotechnology | Diagnostics | Infectious Disease | Polio | Vaccine | WHO
New funding ensured 370 million children receive polio vaccinations in low-income countries
On Oct. 11, 2023, the European Commission, the European Investment Bank and the Bill & Melinda Gates Foundation…
European Commission expanded Merck’s ERVEBO [Ebola Zaire vaccine] indication to include children 1 year of age and older
On Sept. 7, 2023, Merck announced that the European Commission (EC) had approved an expanded indication for ERVEBO…
Roche announced EC approval of Xofluza for treatment and prevention of influenza in children aged one year and above
On Jan. 11, 2023, Roche announced treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis…
EC expanded Merckﾒs VAXNEUVANCEﾙ indication to include infants, children and adolescents
On Oct. 24, 2022, Merck announced that the European Commission had approved an expanded indication for VAXNEUVANCEﾙ (Pneumococcal…
EMA’s CHMP for Human Use issued positive opinion recommending authorization for use of Spikevax in children 6 months – 5 years in EU
On Oct. 19, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
First gene therapy for adults with severe hemophilia A, BioMarin’s ROCTAVIAN, approved by EC
On Aug. 24, 2022, BioMarin Pharmaceutical announced that the European Commission (EC) had granted conditional marketing authorization (CMA)…
Moderna’s Omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrated higher neutralizing antibody response
On Aug. 9, 2022, Moderna announced an amendment to its agreement with the European Commission (EC) to convert…
CHMP adopted positive opinion recommending Vekluryﾮ (Remdesivir) receive full Marketing Authorization for teatment of patients with COVID-19
On Jul. 22, 2022, Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of…
Gilead Sciences signed joint procurement agreement with the European Commission for Vekluryﾮ (Remdesivir)
On Jul. 19, 2022, Gilead Sciences and the European Commission announced a new joint procurement agreement (JPA) that…
Novavax Nuvaxovid COVID-19 vaccine conditionally authorized in EU for adolescents aged 12 through 17
On Jul. 13, 2022, Novavax announced that the European Commission (EC) had approved the expanded conditional marketing authorization…
European Medicines Agency approved SK bioscience as supplier of Novavax Nuvaxovid COVID-19 vaccine
On Jul. 7, 2022, Novavax announced that the European Commission had approved a variation to allow SK bioscience…
Novavax Nuvaxovid COVID-19 vaccine conditionally authorized in EU for adolescents aged 12 through 17
On Jul. 5, 2022, Novavax announced that the European Commission (EC) had approved the expanded conditional marketing authorization…
Moderna and the European Commission agreed on amendment to COVID-19 vaccine supply agreement
On Jun. 2, 2022, Moderna announced an agreement with the European Commission (EC) to amend their originally agreed…
EMA’s Committee for Medicinal Products for Human Use recommended authorization of Covid-19 vaccine in children (6-11 Years) In the EU
On Feb. 24, 2022, Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use…
Pfizer and BioNTech received positive CHMP Opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in EU
On Feb. 24, 2022, BioNTech announced that the Committee for Medicinal Products for Human Use of the European…
EC expanded indication for Veklury (Remdesivir) for treatment of adults not on supplemental oxygen and high risk for COVID-19 progression
On Oct. 21, 2021, Gilead Sciences announced that the European Commission (EC) had approved a variation to the…
European Commission granted conditional Marketing Authorization for Novavax COVID-19 vaccine
On Dec. 20, 2021, Novavax announced that the European Commission (EC) had granted Novavax conditional marketing authorization (CMA)…
World Health Organization granted scond Emergency Use listing for Novavax COVID-19 vaccine
On Dec. 20, 2021, Novavax announced that the World Health Organization (WHO) had granted a second Emergency Use…
Pfizer and BioNTech provided EU more than 200 million additional doses of COMIRNATY for vaccine supply
On Dec. 20, 2021, Pfizer and BioNTech announced an agreement had been reached with the European Commission (EC)…
Pfizer and BioNTech received positive CHMP opinion for COMIRNATYﾮ in children 5 to under 12 years of age in the EU
On Nov. 25, 2021, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
Regeneron antibody cocktail approved by European Commission to treat and prevent COVID-19
On Nov. 12, 2021, Regeneron announced that the European Commission (EC) had approved the casirivimab and imdevimab antibody…