Merck Presents Promising Phase 3 Results for CAPVAXIVE™ Vaccine at IDWeek 2024

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneu...

October 17, 2024 | Thursday | News
InSphero and FDA Publish Landmark Study on Liver Toxicology Using 3D InSight™ Microtissues

 InSphero, the global leader in 3D cell culture technology, and scientists from the U.S. Food and Drug Administration's (FDA) National Cente...

October 16, 2024 | Wednesday | News
Amgen Announces Positive Phase 3 Results for UPLIZNA® in Generalized Myasthenia Gravis, Paving the Way for New Treatment Options

Amgen (NASDAQ:AMGN) announced the presentation of positive top-line results from the Phase 3 MINT trial evaluating the efficacy and safety of UPLIZNA&...

October 16, 2024 | Wednesday | News
Sandoz Launches First FDA-Approved Generic Paclitaxel for Metastatic Breast Cancer

First FDA-approved abbreviated new drug application (ANDA) to reference medicine Single-dose 100 mg vial for intravenous use, approved for metastatic ...

October 14, 2024 | Monday | News
PROCEPT BioRobotics Launches FDA-Approved Trial Comparing Aquablation to Prostatectomy for Cancer Treatment

A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of Aquablation Therapy in Men with Grade Group 1 to 3 Localized Prostate C...

October 08, 2024 | Tuesday | News
Recipharm and Exela Pharma Forge Strategic Alliance to Boost U.S. Sterile Manufacturing with 100+ Million Units Capacity

Sterile manufacturing capability in the US with over 100 million readily-available units (including vials and Pre-Filled Syringes – PFS) Extensi...

October 04, 2024 | Friday | News
Oncocyte's GraftAssure™ Assay Adopted by Top U.S. and German Transplant Hospitals, Progresses Toward FDA Submission

GraftAssure™ research assay adopted by two research hospitals that are top-five-in-country by organ transplant volume Company clears first stage...

October 03, 2024 | Thursday | News
Thryv Therapeutics Secures FDA Orphan Drug Designation for LQT-1213 to Treat Long QT Syndrome

Thryv Therapeutics, a clinical stage biotech company dedicated to developing treatments for rare and life-threatening cardiovascular indications, announced...

October 02, 2024 | Wednesday | News
Astellas Launches DIGITIVA™, a New Digital Health Solution for Heart Failure Management

New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -...

September 19, 2024 | Thursday | News
T2 Biosystems Gains FDA Clearance for Pediatric Use of T2Candida® Panel

T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance gene...

September 17, 2024 | Tuesday | News
FDA Approves Roche’s OCREVUS ZUNOVO™ for Subcutaneous MS Treatment, Expanding Access for Patients

OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's off...

September 16, 2024 | Monday | News
FDA Grants Seven Years of Market Exclusivity to YORVIPATH for Treating Hypoparathyroidism in Adults

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in...

September 12, 2024 | Thursday | News
FDA Issues Warning Letters to Two Chinese Testing Labs Over Data Integrity and Animal Care Violations

Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing U.S. Food and Drug Administration issued warni...

September 12, 2024 | Thursday | News
FDA Approves TREMFYA® as First Dual-Acting Interleukin-23 Inhibitor for Ulcerative Colitis Treatment

The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically signifi...

September 12, 2024 | Thursday | News

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