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
Roche Reports Phase III MUSETTE Trial Results Showing No Additional Benefit from Higher Dose of OCREVUS® in Relapsing MS

Roche announced that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OC...

April 03, 2025 | Thursday | News
DuPont Launches Liveo™ Pharma TPE Ultra-Low Temp Tubing for Demanding Biopharma Processing Needs

  Sterilizable, weldable, sealable thermoplastic elastomer tubing intended for biopharmaceutical processing applications that require low temperature...

April 03, 2025 | Thursday | 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
DDL Expands Capabilities with New GMP Laboratory for Drug-Device Combination Product Testing

DDL, a leading provider of package, product, and material testing services, is pleased to announce the opening of a new Good Manufacturing Practice (GMP) l...

April 01, 2025 | Tuesday | News
Regeneron and Sanofi Receive Approval for Dupixent® in Japan to Treat Chronic Obstructive Pulmonary Disease (COPD)

TARRYTOWN -- Regeneron Pharmaceuticals, and Sanofi announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan ...

March 31, 2025 | Monday | News
CHMP Recommends Opdivo® for EU Approval as Neoadjuvant and Adjuvant Treatment for Resectable NSCLC

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a...

March 31, 2025 | Monday | News
AstraZeneca’s Calquence® Combination Therapy Recommended for EU Approval in Untreated Mantle Cell Lymphoma

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Un...

March 31, 2025 | Monday | News
Akeso Advances Global Leadership in Bispecific Antibodies with Approvals for Ivonescimab and Cadonilimab

Akeso Inc. (9926.HK), a leading biopharmaceutical company, has announced major advancements in its antibody drug pipeline, underscoring a transformative ...

March 31, 2025 | Monday | News
China Grants Breakthrough Therapy Designation to Innovent’s IBI363 for Hard-to-Treat Melanoma

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

March 31, 2025 | Monday | News
Sichuan Kelun-Biotech Secures Approval for First Radionuclide-Drug Conjugate (RDC) Clinical Trial in China

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has received a clinical trial notice approving the inve...

March 26, 2025 | Wednesday | News
FDA Fast-Tracks Tolebrutinib Review for Non-Relapsing Secondary Progressive MS Treatment

The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary pr...

March 26, 2025 | Wednesday | News
CStone Pharmaceuticals Submits EMA Application for Sugemalimab to Treat Unresectable Stage III NSCLC

CStone Pharmaceuticals, a biopharmaceutical company dedicated to developing innovative cancer therapies, announced the submission of a Type II variati...

March 24, 2025 | Monday | News

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