BioSpace News Archive

YourBio Health, Inc, the developers of the world’s first virtually painless push-button blood collection device, announced today that TAP® Micro Select received 510(k) Medical Device clearance from the U.S. Food and Drug Administration (FDA).

Despite the promise of new medications that promote cancer cell death in people with acute myeloid leukemia, leukemic cells often adopt features that let them evade the drugs’ effects within a year.

Can-Fite BioPharma Ltd today announced executive changes to support the Company’s continued success in advancing its pipeline toward commercialization through two pivotal Phase III trials in psoriasis and liver cancer.

Lantheus Holdings, Inc. and POINT Biopharma Global, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC).

ProMIS Neurosciences Inc. today announced data supporting the receptor of activated C-kinase 1 (RACK1) as a potential target in ALS and frontotemporal lobar degeneration with TPD-43-immunoreactive pathology (FTLD-TDP), and updated preclinical data from the Company’s lead candidate for AD, PMN310.

Agenus today announced that Dr. Garo Armen, Chairman and CEO, will participate in the following upcoming investor conferences.

Soligenix, Inc. announced today that the Company has submitted a Type A Meeting Request to the United States (U.S.) Food and Drug Administration (FDA) to initiate formal discussions regarding the design of a second, Phase 3 pivotal study evaluating HyBryte™.

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced the appointment of David Stewart as the new SVP and Site Head of KBI’s mammalian cGMP manufacturing facility in Durham, North Carolina.

bluebird bio, Inc . (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events.

Neurona Therapeutics announced the presentation of updated clinical data from its ongoing Phase I/II clinical trial of a single dose of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE).