Charles River news First-in-class combination therapy authorised for endometriosis
The three-in-one oral daily tablet provides an additional treatment option to help women in the UK manage their endometriosis-associated pain.
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Gene therapy trial facilitates major vision improvement
Results from a Phase I/II gene therapy trial have demonstrated that ATSN-101 enabled patients with a rare inherited disease to gain substantial, rapid improvement in their vision. Participants with Leber congenital amaurosis (LCA1) due to mutations in the GUCY2D gene were evaluated in the one-year clinical trial. Of the 15 participants, three were paediatric subjects.
FDA Seeking Comments on Identifying Priority Focus Areas for Model-Informed Drug Development
On September 3, 2024, the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) issued a Federal Register notice, “Identifying Priority Focus Areas for Future Guidance Development and Engagement with Interested Parties in Model-Informed Drug Development; Request for Information.” FDA welcomes your …
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
Food and Drug Administration approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.