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
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
FDA Approves First Oral Treatment for Postpartum Depression

"Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in sever...

August 07, 2023 | Monday | News
ImPact Biotech Gets FDA Clearance for Padeliporfin VTP Phase 1 in Lung Cancer

 ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administrat...

August 07, 2023 | Monday | News
Etiometry's AI Algorithm FDA Cleared to Alert Neonatal Hypercapnia Risk

Etiometry, the leader in clinical decision-support software, announced today its IVCO2 Index™was cleared by the Food and Drug Administration for use ...

August 03, 2023 | Thursday | News
Spero Therapeutics and FDA Agree on Phase 3 PIVOT-PO Trial for Tebipenem HBr

Spero to receive $30 million development milestone payment from GSK Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutica...

August 01, 2023 | Tuesday | News
FDA Streamlines Innovation for Opioid Use Disorder Devices

"The FDA continues to seek new ways to advance science to address the public health challenges that families and communities across the country face," said...

July 28, 2023 | Friday | News
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic testing algor...

July 26, 2023 | Wednesday | News
Emergent BioSolutions Receives FDA Approval for CYFENDUS™, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorb...

July 21, 2023 | Friday | News
Karyopharm Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis

Regulatory Designation Includes Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis – &ndas...

July 18, 2023 | Tuesday | Regulatory
Melinta Therapeutics Teams Up with BARDA to Advance FDA-Approved Antibiotics for Pediatrics and Biothreat Pathogens

In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M f...

July 11, 2023 | Tuesday | News
Advanced FDA Cleared Magstim Horizon 3.0 TMS Now Available in United Kingdom

The advanced and FDA-cleared Magstim Horizon 3.0 transcranial magnetic stimulation (TMS) system is now UKCA registered and available for sale in the UK, pr...

July 10, 2023 | Monday | News
FDA grants traditional approval for LEQEMBI® for Alzheimer's treatment

The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Nai...

July 07, 2023 | Friday | News

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