BioSpace News Archive

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

Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, will participate at the Morgan Stanley 21st Annual Global Healthcare Conference on September 12 at 12:35 p.m. P.T. / 3:35 p.m. E.T.

Iridex Corporation announced that its Board of Directors is undertaking, in consultation with its financial and legal advisors, a review and evaluation of strategic alternatives that may be available to the Company to unlock shareholder value.

Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that members of management will participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Tuesday, September 12, 2023 at 11:55am PT / 2:55pm ET.

Certara, Inc., a global leader in biosimulation, announced that Company management will participate in the following investor conferences.

FibroGen, Inc. (NASDAQ: FGEN) today announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids.

Novocure (NASDAQ: NVCR) announced today that data from the randomized phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy have been published in The Lancet Oncology.

Medicure Inc. reaffirms its commitment to providing affordable and straightforward access to its branded pitavastatin, ZYPITAMAG®, to people living with HIV through two important channels: its pharmacy subsidiary Marley Drug® and through the AIDS Drug Assistance Program Crisis Task Force formulary.

Akeso released its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization.

Groupe LSL Pharma Inc. announced its financial results for the second quarter ended June 30, 2023.