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
Exactech Announces Clearance for Its New 3D-Printed Vantage® Ankle Tibial Implants

The new implants provide orthopaedic surgeons with additional tibial height options for total ankle replacement patients. Both implants are 3D-printed and ...

October 30, 2023 | Monday | 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
Valneva Submits Chikungunya Vaccine for Accelerated EMA Assessment

VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Appl...

October 26, 2023 | Thursday | 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
Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)

Fezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause More than half of women ages 40 to 64 wor...

October 16, 2023 | Monday | 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
SS Innovations Receives Regulatory Approvals from the Guatemala Ministry of Health

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic tech...

October 11, 2023 | Wednesday | News
Novo Nordisk Halts Weekly Semaglutide Kidney Trial FLOW Due to Interim Analysis

The decision to stop the trial is based on a recommendation from the independent Data Monitoring Committee (DMC) concluding that the results from an interi...

October 11, 2023 | Wednesday | News

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