The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
The U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development, and commercialization of therapies for genetic diseases and vaccines, received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its lead candidate, EXG34217, was approved on May 23, 2020. EXG34217 is an autologous cell therapy for telomere biology disorders with bone marrow failure.
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for BAUSCH + LOMB INFUSE™ daily disposable silicone hydrogel (SiHy daily) contact lenses.
Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma.
Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications.
AgenTus allogeneic iNKTs have potential to clear SARS-CoV-2 virus & mitigate harmful inflammation
Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS).
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year
Submissions supported by two Phase 3 studies in which RINVOQ demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo*
The US FDA has approved Abiomed’s first-in-human trial of the Impella ECP, a temporary percutaneous heart pump that expands once inside the body, allowing for a smaller access site. Read more about the ECP and Abiomed’s early feasibility study.
RECARBRIO is Indicated to Treat Multiple Infections Caused by Susceptible Gram-Negative Bacteria in Adults
Full Results from Phase 2 WILLOW Study of Brensocatib in NCFBE to be Presented at Virtual ATS Session on June 24, 2020
Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public Through Web Order
In the initial scramble to quell the impact of the COVID-19 pandemic, the rapid antibody test market was been flooded. Not all tests are created equal and the COVID-19 crisis introduced the opportunity to try unproven players in rapid diagnostic testing.
High performance, point-of-care rapid test for the detection of Influenza A&B
Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections
Phase 1a/1b dose escalation study to begin in the second half of 2020
FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes
GeneQuantum Healthcare (GQ) has recently received the US IND approval for its in-house developed next generation antibody drug conjugate (ADC) asset, GQ1001.