Novavax Secures EC Approval for Updated 2024-2025 COVID-19 Vaccine
The leading global biotechnology company advancing protein-based vaccines, Novavax, announced that the European Commission has granted Marketing Authorisation for the
Read more
Regulatory
Novavax Wins FDA Emergency Approval for 2024-2025 COVID-19 Vaccine Formula
Novavax, a global leader in protein-based vaccines, has announced that its updated COVID-19 vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), has received
Read more
FDA Approves Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 Vaccine
Pfizer and BioNTech have announced that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application
Read more
ARS Pharmaceuticals’ EURneffy (Adrenaline Nasal Spray) Secures EC Approval
The European Commission has approved EURneffy®, the first and only needle-free adrenaline nasal spray, as an emergency treatment for allergic
Read more
Celltrion’s Omlyclo Gets EC Green Light for Allergic Conditions
The approval is supported by robust clinical evidence, including results from a global Phase III trial. Omlyclo® is the first
Read more
FDA Approves Pfizer’s BEQVEZ™ Gene Therapy for Hemophilia B
Pfizer announced on Friday that the U.S. FDA has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate
Read more
FDA Approves J&J and Bristol Myers Cell Therapies for Refractory Multiple Myeloma
The U.S. Food and Drug Administration has approved the use of cell therapies developed by Johnson & Johnson (JNJ.N) and Bristol Myers Squibb (BMY.N) for treating
Read more
US FDA Approves First Tumor-agnostic HER2-directed Therapy
The US FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as the first tumor-agnostic HER2-directed therapy for the
Read more
FDA Greenlights Iovance’s AMTAGVI™ as First T-cell Therapy for Solid Tumor Cancer
Iovance Biotherapeutics, Inc., a leading biotechnology firm specialising in pioneering, developing, and delivering advanced polyclonal tumor infiltrating lymphocyte (TIL) cell
Read more
Roche’s Tecentriq SC Becomes the EU’s First Approved Subcutaneous Injection PD-(L)1 Cancer Immunotherapy
The European Commission (EC) has granted marketing authorisation for Roche’s Tecentriq® SC (atezolizumab) making it the first European Union PD-(L)1
Read more