BioSpace News Archive

The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.

The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.

The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.

Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield™, Guardant Health’s blood test to screen for colorectal cancer (CRC).

Agilent Technologies Inc. announced it has partnered with Hamamatsu Photonics K.K., a leading provider of whole slide imaging systems, to incorporate their NanoZoomer range including the S360MD Slide scanner system into the Agilent end-to-end digital pathology solution.

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that data from multiple studies of VTAMA® (tapinarof) cream, 1% will be presented at the 2023 American Academy of Dermatology Annual Meeting, to be held from March 17-21 in New Orleans, Louisiana.

Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announces its participation in two upcoming conferences.

Lipocine Inc. announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series B Preferred Stock, par value $0.0001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on March 24, 2023.

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) will discuss Intercept’s new drug application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on May 19, 2023.