NeuroSense Granted Patents in Europe, Japan, and Israel for its ALS Drug PrimeC

Patents valid through 2038 Clinical topline results from Phase 2b ALS trial expected in H2 2023 Corresponding patents have b...

September 21, 2023 | Thursday | News
FDA Acts on Updated mRNA COVID-19 Vaccines for Variant Protection

What You Need to Know Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA C...

September 12, 2023 | Tuesday | News
MedAlliance Enrolls First Patient in SELUTION SLR LOVE-DEB Coronary Study

The aim of the LOVE-DEB Study (Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & ef...

September 06, 2023 | Wednesday | News
ENHERTU® Earns Dual Breakthrough Therapy Designations for HER2-Expressing Cancers in the U.S

Designations for Daiichi Sankyo and AstraZeneca's ENHERTU include patients with HER2 expressing metastatic solid tumors and HER2 positive metastatic colo...

September 04, 2023 | Monday | News
23andMe Granted New FDA Clearance to Report Additional BRCA Variants

510(k) clearance will allow 23andMe to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, prosta...

September 01, 2023 | Friday | News
GE Introduces Vscan Air SL: Handheld Wireless Ultrasound for Quick Cardiac Assessments

With a dual-headed probe, the Vscan Air SL offers a sector array and a linear array on a single device which is ideal for switching between focused cardi...

August 28, 2023 | Monday | News
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

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