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
Oxford BioTherapeutics Announces Boehringer Ingelheim's Fast Track Status for Cancer Treatment

BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 protein DLL3 was discovered using OBT&rsq...

October 04, 2023 | Wednesday | 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
Everest Medicines Secures Taiwan Approval for XERAVA® in Treating Complicated Intra-Abdominal Infections in Adults

"The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections...

September 28, 2023 | Thursday | News
Industry 4.0 for USP 467: Unlocking Lab Productivity Potential

In today’s evolving industrial landscape, the concept of Industry 4.0 is revolutionizing various sectors by leveraging digitalization and automation ...

September 26, 2023 | Tuesday | News
Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Stelara®

“We are thrilled to receive marketing approval for AVT04 in Japan, which will be Alvotech’s second marketed biosimilar,” said Robert Wess...

September 26, 2023 | Tuesday | News

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