BioSpace News Archive

After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.

With Roche’s FDA approval on Thursday, both companies’ bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.

In a unanimous 21-0 vote, an FDA advisory committee recommended an updated monovalent formulation of the COVID-19 vaccine targeting the now-dominant XBB.1.5 subvariant.

The company reported results Friday from the KEYNOTE-811 trial in which the anti-PD-1 therapy took an important step toward FDA approval for rare esophageal tumors.

In the latest HEALEY trial readout, Clene’s CNM-Au8 significantly reduced plasma neurofilament light chain levels in ALS patients, which could be a strong and reliable signal of its clinical benefit.

The Bespoke Gene Therapy Consortium intends to bring AAV-based gene therapies to patients whose diseases are often ignored by commercial interests.

The data for Reproxalap, Aldeyra Therapeutics’ drug for treating allergic conjunctivitis and dry-eye disease, could potentially pave the way for an alternative to over-the-counter eye drops.

The stock deal aims to strengthen Coherus Biosciences’ position in the field of cancer therapeutics and expand its product portfolio.

Better Therapeutics, Inc. announced the details of its poster presentation at the European Association for the Study of the Liver Congress 2023, being held from June 21-24 in Vienna, Austria.

Praxis Precision Medicines, Inc. announced the pricing of its underwritten public offering of 55,150,000 shares of its common stock at a public offering price per share of $0.95 and, in lieu of shares of common stock, a pre-funded warrant to purchase up to an aggregate of 7,050,000 shares of common stock at a purchase price of $0.9499, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant.