Invivyd Urges FDA to Modernize COVID-19 Vaccine Evaluation Through Citizen Petition

Invivyd, Inc. announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from histori...

May 15, 2025 | Thursday | News
Bavarian Nordic Secures UK Approval for VIMKUNYA® Chikungunya Vaccine

Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Ki...

May 05, 2025 | Monday | News
Kytopen and Aldevron Partner to Streamline CRISPR T-Cell Engineering with Breakthrough Non-Viral Workflow

Kytopen Corp., a leader in providing non-viral, continuous flow cellular engineering technologies and Aldevron, a leading global manufacturer serving organ...

May 01, 2025 | Thursday | News
Stablepharma Doses First Participant in Phase 1 Trial of Fridge-Free Tetanus and Diphtheria Vaccine, SPVX02

 Following MHRA approval, Stablepharma Ltd has commenced a Phase 1 clinical trial with its lead candidate, fridge-free tetanus and diphtheri...

April 29, 2025 | Tuesday | News
UB Spin-Off POP Biotechnologies Reports 100% Protection in Preclinical Trials of H5N1 Avian Flu Vaccine

As H5N1 avian influenza continues its spread across species and continents, a vaccine being developed by University of Buffalo (SUNY) spin-off&nb...

April 22, 2025 | Tuesday | News
Henlius Hosts World R&D Day 2025, Showcasing Innovation and Global Collaboration Under "Collaborate to Create" Theme

 Henlius  celebrated its World R&D Day 2025, under the theme "Collaborate to Create", bringing together senior executives, experts and indust...

April 21, 2025 | Monday | News
Akeso Secures NMPA Approval for Ebdarokimab to Treat Moderate-to-Severe Plaque Psoriasis in Adults

Akeso, Inc. is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from ...

April 21, 2025 | Monday | News
CSL Behring Launches ANDEMBRY in Japan for Hereditary Angioedema Prevention

CSL Behring K.K.  President and Representative Director: Izumi Yoshida)  announced that it launched ANDEMBRY® Subcutaneous Injection 200 mg P...

April 21, 2025 | Monday | News
FDA Rejects Regeneron’s Bid for Extended Dosing of EYLEA HD® Beyond 16 Weeks

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding ...

April 21, 2025 | Monday | News
POP Biotechnologies' Nanoparticle Vaccine Shows 100% Protection Against H5N1 Avian Influenza in Preclinical Trials

As H5N1 avian influenza continues its spread across species and continents, a vaccine being developed by University of Buffalo (SUNY) spin-off&nb...

April 18, 2025 | Friday | News
GSK Welcomes ACIP Vote to Recommend Arexvy for At-Risk Adults Aged 50–59

GSK plc is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK&rsquo...

April 17, 2025 | Thursday | News
Pfizer Applauds CDC Panel’s Expanded Recommendation for RSV Vaccination in At-Risk Adults Aged 50–59

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

April 17, 2025 | Thursday | News
Celltrion’s YUFLYMA® Granted FDA Interchangeable Biosimilar Status to Humira®

Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosim...

April 15, 2025 | Tuesday | News
FDA Clears argenx SE’s VYVGART Hytrulo Prefilled Syringe for Patient Self-Injection

argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food a...

April 11, 2025 | Friday | News

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