BioSpace News Archive

Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device.

Diamond Therapeutics Inc. (“Diamond”), a clinical-stage drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the enrollment of the first patient in an FDA-approved clinical trial conducted at the University of Alabama at Birmingham (UAB).

VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received a trio of U.S. Food and Drug Administration (FDA) clearances for its products, providing increased diversity to the company’s portfolio.

Predicine, a pioneer in the liquid biopsy, announce its participation in the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain.

Cingulate Inc. announced that it will be hosting a key opinion leader event on the morning of October 23, 2023, at the Union League Club in New York City.

The Mark Foundation for Cancer Research announced the recipients of its 2023 Endeavor Award program, providing a total of $12M across seven institutions to support teams of scientists tackling a range of urgent challenges in the prevention, diagnosis, and treatment of cancer.

Piramal Pharma Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization, formally announced the launch of a world-class high-throughput screening facility that augments the existing in-vitro biology capabilities at its drug discovery services site in Ahmedabad, India.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Market Authorization for the expanded use of PrTRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 2 to 5 years who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

New research from Shady Grove Fertility (SGF), a US Fertility practice, assures fertility patients who have undergone a saline-infused sonogram (SIS) that they can proceed with intrauterine insemination (IUI) in the same cycle and expect comparable pregnancy rates as if they had waited for another cycle.

Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).