FDA Approves Veklury® for Hepatic Impairment COVID-19 Treatment

Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) f...

August 25, 2023 | Friday | News
Turkey's Ministry of Health Approves Novo Integrated Sciences' IoNovo Iodine

Novo Integrated Sciences, Inc. (NASDAQ: NVOS) (the “Company” or “Novo”),  announced that its IoNovo Iodine product has been gr...

August 23, 2023 | Wednesday | News
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

Abrysvo is administered as a single dose injection into the muscle. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals...

August 22, 2023 | Tuesday | News
Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML

– Enrolled Patients May Continue Receiving Study Medicine – – Studies in Solid Tumors Unaffected – The FDA action follows the pre...

August 22, 2023 | Tuesday | Regulatory
VenusP-Valve Receives IDE Approval for Global Valve Trial, Elevating Chinese Solutions

DE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices...

August 21, 2023 | Monday | News
FDA Prioritizes TARPEYO Full Approval for IgA Nephropathy Treatment

TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progr...

August 21, 2023 | Monday | News
Anika's Integrity™ Implant System Granted 510(k) Clearance for Rotator Cuff Repair Augmentation

Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024 Integrity is highly differentiated by its knitted structure, resulting...

August 21, 2023 | Monday | News
MediciNova Granted New European Patent for Scleroderma Treatment MN-001

This patent is expected to expire no earlier than June 2035. The allowed claims cover the use of MN-001 (tipelukast) for inhibiting or treating sclero...

August 16, 2023 | Wednesday | News
Hong Kong Department of Health has Approved the Registration Applications for the Uro-G and Uro-V Disposable Cystoscopic System

Uro-G offers a viewing angle of 120°, both 210° upward and 130° downward motion angles, and a 90° angle of rotation clockwise and countercl...

August 15, 2023 | Tuesday | News
GE HealthCare's Portrait Mobile Gets FDA Nod for Wireless Patient Monitoring

GE HealthCare’s smart phone-sized Portrait Mobile frees the patient from the hospital bed while providing continuous monitoring of vital signs, usi...

August 15, 2023 | Tuesday | News
Genprex's REQORSA® Granted FDA Orphan Drug Designation for Small Cell Lung Cancer

ODD is in addition to Three FDA Fast Track Designations Genprex expects to dose the first patient in the­­­­ Acclaim-3...

August 11, 2023 | Friday | News
Thermo Fisher to Coordinate Transplant Stats for US NIH

T-SCCC will support initiatives seeking to ensure success of organ transplants for patients The PPD clinical research business of Thermo Fisher Scientific...

August 11, 2023 | Friday | News
Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablati...

August 09, 2023 | Wednesday | News
FDA Approves QIAGEN's Companion Diagnostic for AYVAKIT® in Gastrointestinal Stromal Tumors

QIAGEN announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit). This companion diagn...

August 08, 2023 | Tuesday | News

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