BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A....
Today, Biogen Inc. (Nasdaq: BIIB) announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells, in patients with lupus....
Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”)...
Immunomedics, Inc. (NASDAQ: IMMU), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment ...
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ADP-A2M4 for the treatment of synovial sarcoma...
Alimera Sciences, Inc. (Nasdaq: ALIM), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that the governmental agencies that oversee the availability of medical products in Belgium...
RTI Surgical Holdings (Nasdaq: RTIX), a global surgical implant company, today announced Terry Rich has joined RTI as president of Global Spine. Rich brings to RTI decades of deep spine leadership and commercial success. The company also announced the promotion of Olivier Visa to president of Global OEM...
Amarin (NASDAQ: AMRN), announced today that the European Medicines Agency (EMA) has accepted the company's marketing application for icosapent ethyl (brand name Vascepa in the United States) as a treatment to reduce the risk of cardiovascular events...
CMR Surgical, developer of the Versius Surgical Robotic System, announced the initiation of an investment by GE Healthcare during the company's recent $240 million Series C financing round....
After a successful study which evaluated the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old, the FDA has awarded Tusker Medical breakthrough device approval for their Tula (Tubes Under Local Anesthesia) system, which delivers tympanostomy tubes (ear tubes) to young children with recurrent ear infections, in a physician’s office and under local anesthesia....