Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

LANNETT: Receives FDA Approvals For Two Dosage Strengths Of Butalbital, Acetaminophen And Caffeine Capsules

Lannett Company, Inc. (NYSE: LCI) today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg. The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.

VERO BIOTECH: Receives US FDA Approval of GENOSYL® for the Delivery of Inhaled Nitric Oxide

The GENOSYL® inhaled nitric oxide approval represents the first and only FDA-approved tankless delivery system and is an important new development in the clinical application of inhaled nitric oxide

MERCK: Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Action Represents Another Milestone for the Global Partnership Against Ebola

DAIICHI-SANKYO: ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

U.S. FDA: Approves first generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement

UVISION360: Innovative Femtech Medical Device Company Receives Third FDA Clearance; Expands Choices for LUMINELLE System

UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360˚ Rotatable Disposable Sheath (Diagnostic).

VYAIRE MEDICAL: Proven bellavista™ 1000e Ventilator System Receives FDA Clearance

Innovative ventilation system that can be used across health care settings for full range of patients

CEFALY TECHNOLOGY: U.S. Military Gains Quicker Access to Migraine Relief through FDA-Cleared CEFALY Technology

A new partnership between CEFALY Technology and QB Medical puts wearable medical devices in the hands of health care providers and grants active military immediate relief from migraine headaches

OKAMI MEDICAL: Announces Major Milestones: FDA 510(k) Clearance And Key Patent For The LOBO Vascular Occluder

Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets

LUYE PHARMA: LY03004 Manufacturing Facility Successfully Passes U.S. FDA Pre-approval Inspection with Zero Observation

LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market.

SUNTIVA: Wins 10 BPA Orders with FDA Worth More Than $9 Million

Suntiva, a trusted advisor to leaders in achieving critical business transformation outcomes, is proud to announce that it recently won ten BPA orders with the U.S. Food and Drug Administration (FDA), with a total value of more than $9 million.

FLOWONIX MEDICAL: Receives FDA Approval for its Prometra II® 40 mL Programmable Pump System

Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software.

HKBU: HKBU Drug the First in Hong Kong to be Granted Orphan Drug Designation by the US FDA

A research team from the School of Chinese Medicine at Hong Kong Baptist University (HKBU) has successfully developed a novel aptamer, i.e. a single-stranded piece of DNA, for the treatment of osteogenesis imperfecta (OI) with the aid of artificial intelligence (AI) technology. It is the first time a drug in Hong Kong has been granted orphan drug designation by the US Food and Drug Administration (FDA).

FDA approved record number of generic drugs in 2018

A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.

HERON THERAPEUTICS: Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.

FDA Reporter