FDA Approves Agilent's PD-L1 IHC 22C3 pharmDx for Gastric Adenocarcinoma

Agilent  announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Ga...

November 29, 2023 | Wednesday | News
GE Healthcare Launches Enhanced Digital Expert Access for Remote Patient Scans, Secures Exclusive Distribution Deal with IONIC Health

GE HealthCare (Nasdaq: GEHC) has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access with remote scanning, the first remote pat...

November 22, 2023 | Wednesday | News
Medtronic announces FDA approval of minimally invasive device to treat hypertension

Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology Medtronic plc (NYSE: MDT), a ...

November 20, 2023 | Monday | News
Route 92 Medical Secures $31M in Series F Funding to Boost Expansion in Growing Stroke Treatment Market

The oversubscribed capital raise was led by existing venture capital investors: U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and...

November 17, 2023 | Friday | News
FDA Clears Solid Biosciences' Gene Therapy for Duchenne Muscular Dystrophy

Planning to initiate Phase 1/2 trial in pediatric DMD Patients – – First cohort to study patients 4 to < 6 years of age –   &l...

November 15, 2023 | Wednesday | News
FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at ...

November 10, 2023 | Friday | News
FDA Prioritizes Bristol Myers Squibb's Breyanzi for CLL/SLL Review

Application based on results from TRANSCEND CLL 004, the first pivotal multicenter trial to show clinical benefit with a CAR T cell therapy in heavil...

November 10, 2023 | Friday | News
HUTCHMED announces FDA approval of FRUZAQLA™ for metastatic colorectal cancer in China, by Takeda.

U.S. approval of FRUZAQLA triggers first milestone payment from Takeda of US$35 million and royalties on net sales HUTCHMED (China) Limited (Nasdaq/AIM:HC...

November 09, 2023 | Thursday | News
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

Adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderate...

November 01, 2023 | Wednesday | News
FDA Approves Novartis Cosentyx® as First New Biologic for Hidradenitis Suppurativa in 10 Years

FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as ea...

November 01, 2023 | Wednesday | News
Coherus and Junshi Biosciences Secure FDA Approval for LOQTORZI™ in All NPC Treatment Lines

Indicated in combination with chemotherapy for 1st line treatment and as monotherapy for patients with disease progression on or after platinum containing ...

October 30, 2023 | Monday | News
Zydus India Receives USFDA Approval for ZITUVIO™ to Treat Type 2 Diabetes.

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administra...

October 23, 2023 | Monday | News
FDA Grants Breakthrough Designation to SeaStar Medical's Cytopheretic Device for Hepatorenal Syndrome

SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammatio...

October 19, 2023 | Thursday | News
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

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