Approval broadens DARZALEX label to include fifth treatment option in the relapsed/refractory setting and represents the eighth approved indication for DARZALEX
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).
Approval Based on the CANDOR and EQUULEUS Studies in Patients With Relapsed/Refractory Multiple Myeloma
510(k) Clearance allows 23andMe to report interpretive drug information for medications prescribed for heart conditions and depression without the need for confirmatory testing
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.
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).
Agency Also Announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction
Third FDA-Approved Therapy in Just Over a Year for Neuromyelitis Optica Spectrum Disorder Gives Patients Another Treatment Option
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.
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).
Novel technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.
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.
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.
If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs
Provides additional options to help meet increased demand for continuous renal replacement therapy (CRRT) products resulting from COVID-19 pandemic
The first and only FDA-approved gadolinium-based contrast agent for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.
The Fast Track Designation of AK104 is another significant milestone in the development of this innovative bispecific antibody.
Patients taking VILTEPSO showed an increase in dystrophin expression to an average of 5.9% of normal after 20-24 weeks of treatment.
The U.S. Food and Drug Administration approved Evrysdi (risdiplam) to treat patients two months of age and older with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.
Dovato allows adults living with HIV to reduce the number of antiretroviral therapies they take each day, while maintaining efficacy and high barrier to resistance comparable to tenofovir-based regimens of at least three drugs