STADA, Alvotech Get Positive CHMP Nod for Europe's First Ustekinumab Biosimilar to Stelara

Positive CHMP opinion for Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, includin...

November 13, 2023 | Monday | 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
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

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