Zevra Therapeutics Launches MIPLYFFA™, the First FDA-Approved Treatment for Niemann-Pick Disease Type C

MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra’s specialty pharmacy for dispense AmplifyAssist&...

November 22, 2024 | Friday | News
Avirmax Biopharma Doses First Patient in Phase I/IIa Trial of ABI-110, Pioneering Gene Therapy for Wet AMD and PCV

Avirmax Biopharma, Inc., a leader in the development of innovative gene therapies, announced that the first patient has been successfully dosed in the Phas...

November 22, 2024 | Friday | News
Jazz Pharmaceuticals Secures FDA Approval for Ziihera, First Dual HER2-Targeted Therapy for Advanced Biliary Tract Cancer

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zan...

November 21, 2024 | Thursday | News
Abzena Expands Analytical Capabilities with GMP Cell-Based Potency Assays at Cambridge and San Diego Facilities

" Abzena, a leading CDMO/CRO, now offers GMP cell-based potency assays at its UK and US sites, enhancing its support for complex biologics and ADC programs...

November 20, 2024 | Wednesday | News
AstraZeneca’s Tagrisso (osimertinib) Recommended for EU Approval in Unresectable EGFR-Mutated Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with ...

November 19, 2024 | Tuesday | News
Eli Lilly Announces Positive Phase 2 Results for Muvalaplin, Oral Treatment for Elevated Lp(a) Levels and Heart Disease Risk

Eli Lilly and Company (NYSE: LLY) announced positive Phase 2 results for muvalaplin, an investigational once-daily, orally administered selective inhi...

November 19, 2024 | Tuesday | News
European Commission Approves OPUVIZ™ (SB15), a Biosimilar to Eylea, for Treatment of Retinal Disorders

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution...

November 19, 2024 | Tuesday | News
Fate Therapeutics Presents Promising Initial Data for FT819 in Lupus Nephritis at ACR Convergence

Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent s...

November 19, 2024 | Tuesday | News
Rona Therapeutics’ RN0191 Demonstrates Significant LDL-C Reduction in Phase 1 Trial

Rona Therapeutics, a leader in innovative RNA-based therapies, presented positive results from the Phase 1 clinical trial of RN0191 at the American Heart A...

November 18, 2024 | Monday | News
Alnylam’s Nucresiran Achieves Rapid and Sustained TTR Reduction in Phase 1 Study for ATTR Amyloidosis

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced the presentation of new results from its Phase 1 study ...

November 18, 2024 | Monday | News
Tirzepatide Significantly Reduces Heart Failure Risk in Obese Patients with Preserved Ejection Fraction, New Data Show

Eli Lilly and Company (NYSE: LLY) announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening ...

November 18, 2024 | Monday | News
EMA Committee Recommends Approval of Opdivo® + Yervoy® for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...

November 18, 2024 | Monday | News
FDA Accepts Resubmission for Dupixent to Treat Chronic Spontaneous Urticaria (CSU)

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (d...

November 18, 2024 | Monday | News
Amgen Presents New Data on UPLIZNA and KRYSTEXXA at ACR Convergence 2024

Amgen (NASDAQ:AMGN) announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheum...

November 15, 2024 | Friday | News

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