FDA Prioritizes TARPEYO Full Approval for IgA Nephropathy Treatment

TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progr...

August 21, 2023 | Monday | News
Anika's Integrity™ Implant System Granted 510(k) Clearance for Rotator Cuff Repair Augmentation

Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024 Integrity is highly differentiated by its knitted structure, resulting...

August 21, 2023 | Monday | News
TAE Life Sciences Partners with Biddle Sawyer for Cancer Treatment Drug

TAE Life Sciences has  announced a landmark agreement with Biddle Sawyer to serve as the exclusive supplier of TC220, a novel boronated amino aci...

August 16, 2023 | Wednesday | News
Sequel Spiral™ Tampon Receives FDA Approval as Medical Device

-Sequel, a startup, dedicated to engineering better health and wellness experiences for women, today announced that its breakthrough spiral tampon has rece...

August 16, 2023 | Wednesday | News
GE HealthCare's Portrait Mobile Gets FDA Nod for Wireless Patient Monitoring

GE HealthCare’s smart phone-sized Portrait Mobile frees the patient from the hospital bed while providing continuous monitoring of vital signs, usi...

August 15, 2023 | Tuesday | News
Pfizer's ELREXFIO™ Granted U.S. FDA Accelerated Approval for Refractory Multiple Myeloma

The approval of ELREXFIO (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study EL...

August 15, 2023 | Tuesday | News
Zumutor's ZM008 Monoclonal Antibody Clears FDA IND for Solid Cancers

FDA also accepted the "safety first" staggered parallel clinical design of ZM008 combination arm with Pembrolizumab to benefit a wider range of patients wh...

August 14, 2023 | Monday | News
Genprex's REQORSA® Granted FDA Orphan Drug Designation for Small Cell Lung Cancer

ODD is in addition to Three FDA Fast Track Designations Genprex expects to dose the first patient in the­­­­ Acclaim-3...

August 11, 2023 | Friday | News
Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablati...

August 09, 2023 | Wednesday | News
FDA Approves QIAGEN's Companion Diagnostic for AYVAKIT® in Gastrointestinal Stromal Tumors

QIAGEN announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit). This companion diagn...

August 08, 2023 | Tuesday | News
FDA Approves First Oral Treatment for Postpartum Depression

"Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in sever...

August 07, 2023 | Monday | News
ImPact Biotech Gets FDA Clearance for Padeliporfin VTP Phase 1 in Lung Cancer

 ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administrat...

August 07, 2023 | Monday | News
Etiometry's AI Algorithm FDA Cleared to Alert Neonatal Hypercapnia Risk

Etiometry, the leader in clinical decision-support software, announced today its IVCO2 Index™was cleared by the Food and Drug Administration for use ...

August 03, 2023 | Thursday | News
Spero Therapeutics and FDA Agree on Phase 3 PIVOT-PO Trial for Tebipenem HBr

Spero to receive $30 million development milestone payment from GSK Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutica...

August 01, 2023 | Tuesday | News

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