BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

ImmunityBio, Inc today announced that it has achieved a major milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14, 2022.

ImmunoGen, Inc. announced that on March 31, 2022, the compensation committee of the Company’s Board of Directors approved grants of non-qualified stock option awards to purchase an aggregate of 218,500 shares of its common stock to three new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan, as amended.

ASLAN Pharmaceuticals, announced that on March 28, 2022, it received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC indicating that the Company is not in compliance with the US$1.00 minimum bid price requirement under the Nasdaq Listing Rules.

Assembly Biosciences, Inc. announced a grant of stock options to one new employee to purchase 19,000 shares of the Company’s common stock with an exercise price of $2.06 per share, the closing price of Assembly Bio’s common stock on April 1, 2022.

Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence -empowered drug discovery, announces that the China National Medical Products Administration has cleared the company’s investigational new drug application for AC0682 for the treatment of patients with estrogen receptor -positive breast cancers.

Kestra Medical Technologies announced that the company’s ASSURE® Wearable Cardioverter Defibrillator system is effective at reducing false-positive shock alarms according to results of the ASSURE WCD Clinical Evaluation - Detection and Safety Study published in the Journal of Cardiovascular Electrophysiology.

Oral mucositis is a painful and potentially treatment-limiting disorder often associated with radiation therapy and chemotherapy of the head, neck and throat cancers, yet mucositis also impacts a large percentage of patients being treated for other cancers.

Tricida, Inc. announced that it will present at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11, 2022 at 10:30 am Pacific Time / 1:30 pm Eastern Time.

Work completed thus far on the parent molecule, cepharanthine by PharmaDrug and others, potentially de-risks and expedites several aspects of these studies.