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NOVADOZ PHARMACEUTICALS: FDA Approvals of Oseltamivir and Dofetilide Continues the Company's Rise in the Generic Market

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules.

GENENTECH: FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer

Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma

LETSGETCHECKED: Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test

FDA EUA-authorized at-home Coronavirus test is now available in the United States, offering unparalleled safety and scale for consumers

EXPRESSION THERAPEUTICS: Announces IND Approval by the FDA for Hemophilia A Gene Therapy

Expression Therapeutics has announced that it has received clearance by the United States Food and Drug Administration (FDA) to proceed following review of its Investigational New Drug Application (IND) for clinical testing of its novel lentiviral vector-based gene therapy — ET3 — for hemophilia A.

SMART MEDICAL SYSTEMS: Receives FDA Clearance for Its G-EYE® Colonoscope

SMART's G-EYE® Colonoscope, incorporating the G-EYE® Balloon Technology which helps control the endoscope's field of view and positioning during colonoscopy, was cleared for marketing in the USA by FDA

HIKMA: Receives FDA approval for its generic Vascepa®

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Vascepa®.

MARENA: Georgia-Based Healthcare Manufacturer, Marena, to Supply Poll Workers With FDA-Approved Face Masks Ahead of June Primary

The Marena Group LLC, a Georgia-based medical device manufacturer, announced that they will be supplying Georgia election and poll officers with 35,000 masks for protection against COVID-19.

THERMEDICAL: Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation

Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter.

EVERLYWELL: COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind

Everlywell's FDA-authorized home collection kit for COVID-19 will be available for individuals and organizations later this month

OPTINA DIAGNOSTICS: Receives 510(k) clearance from U.S. FDA for its MHRC-C1, permitting hyperspectral imaging of the retina

Optina Diagnostics announces today that it received 510(k) clearance for its ophthalmic camera, the Mydriatic Hyperspectral Retinal Camera (MHRC-C1), by the U.S. Food and Drug Administration (FDA).

TRANSIT SCIENTIFIC: FDA Clears New XO Cross Microcatheter Platform

New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature

ABBOTT: Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity™ i System

Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system.

FDA: Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or "rearranged during transfection"). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.

CONTROL MEDICAL TECHNOLOGY: FDA Clears New Mechanical Thrombectomy Platform

New large catheter platform FDA cleared to remove blood clots from peripheral vessels

SCIBASE: Receives FDA Approval for Nevisense 3.0

SciBase (SCIB) Stockholm, Sweden - announced today that it has received approval from the US Food and Drug Administration (FDA) for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection.

FDA Reporter