BioSpace News Archive

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.

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 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.

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.

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

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

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

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.

Innate Pharma SA announced that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody.

RELIEF THERAPEUTICS Holding SA announced it has entered into a definitive agreement for the sale and purchase in a private placement of 1,500,000 ordinary shares of Relief Therapeutics and warrants to purchase up to 1,500,000 ordinary shares at a purchase price of CHF 3.33 per share and associated warrant.