Gilead Sciences, Inc. agreed to collaborate on the Strata Precision Indications for Approved THerapies (PATH) trial by providing Trodelvy (sacituzumab govitecan-hziy) for eligible patients with cancer.
Elicio Therapeutics has entered into a definitive merger agreement with Angion Biomedica Corp under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction.
FDA has accepted Genentech’s Biologics License Application and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Foundation Medicine Inc. and Natera Inc. launched an early access program for clinical use of FoundationOne Tracker, a personalized circulating tumor DNA monitoring assay.
Kronos Bio Inc. and Genentech entered into a discovery collaboration focused on discovering and developing small-molecule drugs that modulate transcription factor targets selected by Genentech.
FDA granted accelerated approval to Lunsumio (mosunetuzumab-axgb), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.
FDA approved a new indication for Cytalux (pafolacianine) to assist surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer.
FDA accepted, for priority review, supplemental Biologics License Applications for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.Â
The Independent Expert Panel for Tobacco submitted its recommendations to Commissioner Robert Califf at FDA. The Operational Evaluation of FDA’s Tobacco Program was facilitated by the Reagan-Udall Foundation at the Commissioner’s request.
