Tuesday, May 7, 2024

Tuesday, May 7, 2024

Latest News

ABBVIE: Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis

Patients

By Press release submission | Aug 16, 2019

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).1 RINVOQ is expected to be available in the U.S. in late August 2019.

NATIONAL KIDNEY FOUNDATION: IgA Nephropathy Patients Invited to Speak About their Disease to the FDA

Patients

By Press release submission | Aug 16, 2019

National Kidney Foundation and IGAN Foundation of America organizing meeting to hear voices of patients with this chronic kidney disease

EDWARDS LIFE SCIENCES CORPORATION: Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

Patients

By Press release submission | Aug 17, 2019

Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis

PROFOUND MEDICAL: Receives U.S. FDA 510(k) Clearance for TULSA-PRO®

FDA Approval

By Press release submission | Aug 17, 2019

U.S. Commercial Launch Expected in the 4th Quarter of 2019

ADAGIO MEDICAL: Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System

FDA Approval

By Press release submission | Aug 19, 2019

Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company's ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial fibrillation (AF).

BOSTON SCIENTIFIC CORPORATION: Announces FDA Approval Of ImageReady™ MRI For Vercise Gevia™ Deep Brain Stimulation System

FDA Approval

By Press release submission | Aug 19, 2019

Boston Scientific Corporation (NYSE:BSX) announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™ Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment.

VANDA PHARMACEUTICALS: FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder

Patients

By Press release submission | Aug 20, 2019

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on August 16 2019, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of Jet Lag Disorder (JLD).

VYAIRE MEDICAL: Receives FDA Clearance of New Pulmonary Function Testing Technology

FDA Approval

By Press release submission | Aug 20, 2019

Vyntus™ ONE, Vyntus™ BODY and SentrySuite™ Software Available to U.S. Healthcare Market Immediately

BIOELECTRONICS CORPORATION: Files FDA 510(k) Application for Musculoskeletal Pain Complaints; Clinical Data Demonstrates Superior Drug Free Pain Relief to Prescription Strength NSAID Drug

Regulation

By Press release submission | Aug 21, 2019

BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, is pleased to announce that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration (FDA).

BEIGENE: Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Patients

By Press release submission | Aug 21, 2019

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

STALICLA: Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD)

Patients

By Press release submission | Aug 22, 2019

STP1 is a pioneering investigational precision medicine that aims to provide an effective treatment option for a subgroup of patients with ASD (referred to as ‘Phenotype 1’). Phenotype 1 is estimated to include 20% of the total ASD population (2 million out of 10 million patients with ASD across Europe and North America), meaning STP1 has the potential to be a ‘game-changing’ influence in the field.

SURGENTEC: Announces FDA Clearance for Neurostimulation with ALARA™ Access Needle Kit

FDA Approval

By Press release submission | Aug 22, 2019

Announces Participation in the 2019 North American Spine Society (NASS) Annual Meeting

FDA approvals of new drugs, biological products dip slightly in FY2019

FDA Approval

By FDA Reporter Submission | Aug 22, 2019

New drug and biological product approvals were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

MIRACOR MEDICAL: Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

FDA Approval

By Press release submission | Aug 23, 2019

Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients.

SEELOS THERAPEUTICS: Announces FDA Acceptance of IND Application for SLS-005 for Mucopolysaccharidosis Type III (Sanfilippo Syndrome)

FDA Approval

By Press release submission | Aug 23, 2019

Seelos to Proceed with Trial Enrollment and Dosing for Phase IIb/III Trial for Sanfilippo Syndrome Type A and B Patients

FDA to unveil new warning labels for cigarettes

Regulation

By John Severance | Aug 24, 2019

The U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.

New cloud-based vital signs measurement system approved by FDA

FDA Approval

By Keri Carbaugh | Aug 24, 2019

The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.

FDA warning about the side effects of Miracle Mineral Solution

FDA Approval

By Keri Carbaugh | Aug 24, 2019

The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.

FDA reviews data manipulation in AveXis' new gene therapy drug for children

FDA Approval

By Kayla Elder | Aug 25, 2019

One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.

BIOBEAT: First-ever: FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure

FDA Approval

By Press release submission | Aug 26, 2019

Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Biobeat's products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway.

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  1. 1 FUNCTIONAL NEUROMODULATION: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer's Disease
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