Approval Tracker
A tracked regulation dataset for our medical research coverage: what it measures, where the figures come from and when they were last checked.
FDA delays Exelixis' zanzalintinib decision to March 2027
The FDA has postponed its approval decision for Exelixis' oral kinase inhibitor zanzalintinib in metastatic colorectal cancer, requesting updated...
FDA approves AstraZeneca's Etcamah for ctDNA-guided breast
The FDA granted accelerated approval to AstraZeneca's camizestrant (Etcamah) for HR-positive, HER2-negative breast cancer patients with an ESR1...
Ionis' Zanvastro Wins First FDA Approval for Alexander
The FDA has approved Ionis Pharmaceuticals' Zanvastro, the first treatment for the rare neurological disorder Alexander disease.
FDA Grants Accelerated Approval to AstraZeneca's Etcamah
The FDA has granted accelerated approval to AstraZeneca's Etcamah for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations, based on...
UniQure Seeks FDA Approval for Huntington's Gene Therapy
UniQure has submitted AMT-130, a gene therapy for Huntington's disease, to the FDA for accelerated approval based on three-year data showing it can...
FDA approval ignites orexin drug race
Takeda's orexin-mimicking drug Orzeyful won FDA approval in August for narcolepsy type 1, with experts dubbing the class the 'GLPs of neuroscience'...
Revolution's pancreatic cancer drug Rasonque cleared by FDA
Revolution Medicines' pancreatic cancer therapy Rasonque cleared FDA approval via priority review voucher, marking a major advance for second-line...
Revolution Medicines' Rasonque Approved for Pancreatic Cancer
The FDA has approved Rasonque, a new pancreatic cancer drug by Revolution Medicines, marking the first treatment to target a genetic cause of the...
Daraxonrasib Approved for Metastatic Pancreatic Cancer
The FDA has granted approval to the RAS inhibitor daraxonrasib for adults with metastatic pancreatic ductal adenocarcinoma who have progressed on...
Capricor’s Duchenne Drug Study Highlights the Challenges of Rare Disease Trials
The FDA's recent decision on Capricor’s deramiocel for Duchenne muscular dystrophy underscores the complexities of rare disease clinical trials...
Regeneron's Pasatru Receives FDA Approval for Rare Bone Disease
Regeneron Pharmaceuticals' Pasatru has earned FDA approval for treating fibrodysplasia ossificans progressiva, a rare condition causing abnormal bone...
FDA Clears Bristol Myers Squibb's Oral Multiple Myeloma Therapy, Introducing First-in-Class Agent
The U.S. FDA has approved Bristol Myers Squibb’s oral drug iberdomide, marketed as Zenbexus, for use with daratumumab and dexamethasone in patients...