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
INVO Fertility Rebrands and Refocuses on Fertility Services, Separates Oncology Operations

INVO Fertility, Inc., formerly known as NAYA Biosciences, Inc., a healthcare services fertility company focused on expanding access to advanced treatment t...

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
FDA Approves Opdivo® Plus Yervoy® as First-Line Treatment for MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy®...

April 10, 2025 | Thursday | News
Shilpa Pharma Lifesciences Passes Second Consecutive FDA Inspection with No Observations

Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Admin...

April 10, 2025 | Thursday | News
Science 37 Achieves Second Successful FDA Inspection, Reaffirming Commitment to High-Quality Clinical Trials

Science 37, a leader in enhancing patient access to clinical trials, announced the successful completion of its second FDA inspection, reaffirming the qual...

April 10, 2025 | Thursday | News
CareMed Joins Limited Distribution Network for Vanrafia™ (Atrasentan) in Treatment of Primary IgAN

CareMed, an independent specialty pharmacy, is in the Limited Distribution Network for Vanrafia™ (atrasentan), for the reduction of proteinuria ...

April 08, 2025 | Tuesday | News
AVITA Medical Launches Cohealyx™ in the U.S., Expanding Portfolio for Transformative Acute Wound Care

AVITA Medical, Inc., a leading therapeutic acute wound care company delivering transformative solutions, announced the U.S. commercial launch of Cohealyx&t...

April 07, 2025 | Monday | News
Mesoblast Confirms U.S. Tariff Exemption for Allogeneic Cellular Products, Including Ryoncil® and Revascor®

Mesoblast, global leader in allogeneic cellular medicines for inflammatory diseases, provided an update on the status of its products in relation to the U....

April 04, 2025 | Friday | News
Amgen’s UPLIZNA Receives FDA Approval as First Treatment for IgG4-Related Disease, Cutting Flare Risk by 87%

Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo  UPLIZNA Shown to De...

April 04, 2025 | Friday | News
Novartis Receives FDA Accelerated Approval for Vanrafia® in Treatment of Primary IgA Nephropathy

Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective e...

April 03, 2025 | Thursday | News
Biogen’s BIIB080 Receives FDA Fast Track Designation for Alzheimer’s Disease Treatment

Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oli...

April 03, 2025 | Thursday | News
Innovent Biologics’ IBI363 Receives Breakthrough Therapy Designation from China’s NMPA for Melanoma Treatment

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment o...

April 02, 2025 | Wednesday | News

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