Linkedin
RLS logo_header
Linkedin

PDUFA Date Extension for Nirogacestat NDA Announced

“We are confident that the comprehensive data from our Phase 3 DeFi trial demonstrate the transformative benefits that nirogacestat can bring to people with desmoid tumors, who currently do not have an approved therapy,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We remain committed to bringing this much needed therapy to patients and believe that our operational and manufacturing readiness positions us well to rapidly serve the desmoid tumor community following an approval. We look forward to continuing to work closely with the FDA as they complete their review of the nirogacestat NDA.”

Read the full story on "PDUFA Date Extension for Nirogacestat NDA Announced"

Share:

More News

Gotistobart Nearly Doubled Median OS versus SOC Chemo in Previously Treated Squamous NSCLC Patients

“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel

Ratio Therapeutics Enters into Research Collaboration and License Agreement with RayzeBio to Advance a Novel Radiopharmaceutical Program

“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated

Zipalertinib + chemo Demonstrates 6-Month Median PFS Benefit in REZILIENT3 Ph 3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with

FDA clears IND application to initiate Ph 1 study for PRT13722 for HR+/HER2- breast cancer patients

“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines