FDA Grants Fast Track Designation to Sanofi’s Combination Vaccines for Influenza and COVID-19 in Older Adults

The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infec...

December 13, 2024 | Friday | News
Sanofi Advances First Non-mRNA Flu-COVID Combination Vaccines with FDA Fast Track Designation

First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections Two phase 1/2 cl...

December 11, 2024 | Wednesday | News
European Commission Approves Single-Vial, Fully Liquid Menveo® Vaccine for Protection Against Meningococcal Disease

GSK plc (LSE/NYSE: GSK) announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococca...

November 28, 2024 | Thursday | News
GSK’s Arexvy RSV Vaccine Approved in Japan for Adults Aged 50-59 at Increased Risk

GSK plc (LSE/NYSE: GSK) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indi...

November 25, 2024 | Monday | News
European Commission Approves OPUVIZ™ (SB15), a Biosimilar to Eylea, for Treatment of Retinal Disorders

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution...

November 19, 2024 | Tuesday | News
Rona Therapeutics’ RN0191 Demonstrates Significant LDL-C Reduction in Phase 1 Trial

Rona Therapeutics, a leader in innovative RNA-based therapies, presented positive results from the Phase 1 clinical trial of RN0191 at the American Heart A...

November 18, 2024 | Monday | News
Arcturus Therapeutics Receives FDA Green Light for Clinical Trial of sa-mRNA Vaccine Targeting Pandemic H5N1 Influenza

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focus...

November 12, 2024 | Tuesday | News
Health Canada Approves Moderna’s mRESVIA™ RSV Vaccine for Adults 60 and Older

Moderna, Inc. (NASDAQ:MRNA) announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active immunization for the ...

November 11, 2024 | Monday | News
Ardena Expands Bioanalytical Services with New Lab in Oss, Netherlands, Enhancing Capabilities to Meet Growing Client Demand

  Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organisation (CDMO) with GMP facilities in Belgium, Spain, the Netherlan...

October 31, 2024 | Thursday | News
AstraZeneca’s Fasenra Receives EU Approval as Add-On Treatment for Eosinophilic Granulomatosis with Polyangiitis

AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing ...

October 29, 2024 | Tuesday | News
GSK Announces Promising Data for Arexvy Vaccine in Younger Adults at Risk for RSV

GSK plc (LSE/NYSE: GSK) announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at inc...

October 25, 2024 | Friday | News
Pfizer Expands Pneumococcal Vaccine Recommendations for Adults 50 and Older Following CDC Advisory Committee Vote

Pfizer Inc. (NYSE: PFE) announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP)...

October 24, 2024 | Thursday | News
Sanofi and CD&R Announce Exclusive Negotiations for 50% Stake in Opella, Poised to Create Global Consumer Healthcare Leader

 Sanofi and CD&R announce a plan to join forces to fuel Opella’s ambitions as a French-headquartered, global consumer healthcare champion. S...

October 22, 2024 | Tuesday | News
Merck Presents Promising Phase 3 Results for CAPVAXIVE™ Vaccine at IDWeek 2024

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneu...

October 17, 2024 | Thursday | News

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