August, 2020 Stories | FDA Health News

Enzychem Lifesciences (KOSDAQ: 183490) announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate its lead therapeutic candidate EC-18, in a Phase 2 clinical trial in patients with Acute Respiratory Disease Syndrome (ARDS) due to COVID-19 pneumonia. A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea.

HYPERFINE: Research Receives 510(k) Clearance from US FDA for Market-Ready Swoop™ Portable MRI System

Reform

Novel technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.

RAPIDAI: Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions

RapidAI, the worldwide leader in advanced imaging for stroke, today announced that Rapid LVO has received Food and Drug Administration (FDA) clearance for detecting suspected LVOs (Large Vessel Occlusions).

MASIMO: PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients

Patients

Masimo (NASDAQ: MASI) announced that PVi® has received FDA clearance as a continuous, noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

FDA: Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

By Press release submission | Aug 19, 2020

Third FDA-Approved Therapy in Just Over a Year for Neuromyelitis Optica Spectrum Disorder Gives Patients Another Treatment Option

FDA: Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

By Press release submission | Aug 20, 2020

Agency Also Announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction

UNITED THERAPEUTICS: Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Tyvaso® For Pulmonary Hypertension Associated With Interstitial Lung Disease

By Press release submission | Aug 22, 2020

United Therapeutics Corporation (Nasdaq: UTHR) announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

KIMERA® LABS: Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

Drug Shortages

By Press release submission | Aug 22, 2020

Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes.

23ANDME: Granted New FDA Clearance to Provide Interpretive Drug Information for Two Commonly Prescribed Medications

By Press release submission | Aug 22, 2020

510(k) Clearance allows 23andMe to report interpretive drug information for medications prescribed for heart conditions and depression without the need for confirmatory testing

AMGEN: FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone In Both Once- And Twice-Weekly Dosing Regimens

Approval Based on the CANDOR and EQUULEUS Studies in Patients With Relapsed/Refractory Multiple Myeloma

NOVARTIS PHARMACEUTICALS CORPORATION: FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

By Press release e submission | Aug 23, 2020

Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)

AMIDEBIO, LLC: U.S. FDA grants rare pediatric disease designation to AmideBio's glucagon analog for the treatment of congenital hyperinsulinism

AmideBio, LLC, a privately held biopharmaceutical company, announced that the US Food and Drug Administration (FDA) Offices of Pediatric Therapeutics and Orphan Products Development granted a rare pediatric disease designation to AmideBio's glucagon analog (AB-G023) for the treatment of congenital hyperinsulinism (CHI).

JANSSEN: U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Approval broadens DARZALEX label to include fifth treatment option in the relapsed/refractory setting and represents the eighth approved indication for DARZALEX

KAZIA THERAPEUTICS LTD: US FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG

Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.

LUNGEVITY: Launches Lung Cancer Patient Research Project in Collaboration with the FDA

Patients

By Press release submission | Aug 28, 2020

The new multi-year study will seek to understand different aspects of the patient experience with lung cancer to improve treatment options and outcomes

HEALEON: Announces FDA 510(k) Clearance for Duet Office-Based Blood Separation and Concentration System

By Press release submission | Aug 28, 2020

Healeon Duet enables customized concentrations of PRP at the point-of-care

REGENXBIO: Announces FDA Clearance of IND for Phase II Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

Company expects to initiate enrollment in the Phase II trial, ALTITUDE, in the second half of 2020 to evaluate the targeted, in-office suprachoroidal delivery of RGX-314

ABBVIE: Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis

RINVOQ demonstrated significant improvements to signs and symptoms of active ankylosing spondylitis[

EMD SERONO: FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations

Patients

Tepotinib granted Priority Review and is being evaluated under FDA Real-Time Oncology Review (RTOR) pilot program

RECORDATI RARE DISEASES INC.: U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis