BioSpace News Archive

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription.

BD announced that it will report its fiscal 2021 fourth quarter and full year financial results on Thursday, Nov. 4, 2021.

Renovacor, Inc., a biotechnology company developing adeno-associated virus ‑based gene therapies for devastating cardiovascular and central nervous system diseases resulting from BAG3 gene variants, announced the appointment of Kumar Dhanasekharan, Ph.D., as Senior Vice President of Technical Operations.

NeoChord, Inc., a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr).

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it has added advanced tissue, biofluid and cell search and e-commerce capabilities to its website at www.bioivt.com.

Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the publication of a study demonstrating, through the use of a Medtronic continuous rhythm monitoring device, that atrial fibrillation (AF) is directly and transiently associated with ischemic stroke.

The FY22 NDAA report calls for the Department of Defense (DoD) to continue investments in promising therapeutics, like NervGen’s NVG-291, for the treatment of nervous system disorders, including TBI.

InFlectis BioScience SAS, a clinical-stage company developing innovative therapeutics for neuromuscular diseases by harnessing the Integrated Stress Response (ISR), expands its leadership team with three appointments.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.

Himalaya Therapeutics (“Himalaya”), today announced that it has submitted four investigational new drug (IND) applications to the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA).