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
Yingli Pharma Receives FDA Clearance to Launch Phase 3 Trial for Linperlisib in Relapsed/Refractory PTCL

Shanghai Yingli Pharmaceutical Co., Ltd., a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune dis...

April 02, 2025 | Wednesday | News
Trump Administration Cuts 10,000 Federal Health Jobs, Sparking National Outcry

Massive Health Workforce Shake-Up: 10,000 Federal Health Agency Employees Face Layoffs Amid Budget Axes Trump administration has begun...

April 02, 2025 | Wednesday | News
FDA Approves Freeze-Dried Formulation of JYNNEOS® for Smallpox and Mpox Prevention

Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS® (Smallpox and...

April 01, 2025 | Tuesday | News
Alnylam Presents New Data from HELIOS-B Trial at ACC.25, Highlighting Vutrisiran’s Impact on ATTR-CM Treatment

Alnylam Pharmaceuticals, Inc. , the leading RNAi therapeutics company, announced moderated poster presentations of new data from the landmark HELIOS-B...

March 31, 2025 | Monday | News
Novartis Announces FDA Approval for Expanded Use of Pluvicto® in mCRPC, Tripling Eligible Patient Access

Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with pro...

March 31, 2025 | Monday | News
FDA Approves CABOMETYX® for Treatment of Advanced Neuroendocrine Tumors in Adults and Pediatric Patients

 Exelixis, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the tre...

March 28, 2025 | Friday | News

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