GE HealthCare Gets FDA Clearance for Allia IGS Pulse: Next-Gen Cardiac Imaging System

Building on the award-winning Allia platform for image guided therapies, the new Allia IGS Pulse was designed to improve workflow for the diagnosis and t...

October 17, 2023 | Tuesday | News
FDA Approves Etrasimod by Pfizer for Severe Ulcerative Colitis

Everest Medicines  announced  that its licensing partner, Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administratio...

October 16, 2023 | Monday | News
FDA Clears Pfizer's BRAFTOVI® + MEKTOVI® for Lung Cancer with BRAF V600E Mutation

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) fo...

October 13, 2023 | Friday | News
FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®

TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non...

October 02, 2023 | Monday | News
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

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