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
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

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