BAYER: FDA Approves Gadavist® (gadobutrol) Imaging Bulk Package
The first and only FDA-approved gadolinium-based contrast agent for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.
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BAXTER: Obtains U.S. FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic
Provides additional options to help meet increased demand for continuous renal replacement therapy (CRRT) products resulting from COVID-19 pandemic
GENENTECH: FDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications
If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs
SCHOLAR ROCK: Announces that SRK-015 has Received Rare Pediatric Disease Designation from U.S. FDA for the Treatment of Spinal Muscular Atrophy
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for SRK-015 for the treatment of Spinal Muscular Atrophy (SMA), a progressive, rare genetic disease that leads to motor function impairments.
ENZYCHEM LIFESCIENCES: Announces FDA Acceptance of Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia
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
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
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
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
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
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
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
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
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
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
Healeon Duet enables customized concentrations of PRP at the point-of-care