Agilent Receives European IVDR Certification for Companion Diagnostic Assay

PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA® (pembrolizumab), Merck&r...

August 25, 2023 | Friday | News
FDA Approves Veklury® for Hepatic Impairment COVID-19 Treatment

Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) f...

August 25, 2023 | Friday | News
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

Abrysvo is administered as a single dose injection into the muscle. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals...

August 22, 2023 | Tuesday | News
Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML

– Enrolled Patients May Continue Receiving Study Medicine – – Studies in Solid Tumors Unaffected – The FDA action follows the pre...

August 22, 2023 | Tuesday | Regulatory
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

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