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 Approves Voceryq for Recurrent Respiratory Papillomatosis
The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis...
Intismeran-Keytruda combo cuts melanoma recurrence risk by 42%
A Phase 3 trial shows Moderna's intismeran vaccine combined with Merck's Keytruda reduces the risk of recurrence or death in high-risk melanoma...
GSK and Ionis win first FDA approval for hepatitis B functional cure
The FDA has approved GSK and Ionis's RNA-based drug Hibsago, offering a functional cure for chronic hepatitis B in adults without cirrhosis after a...
FDA expands Anktiva approval for BCG-unresponsive bladder cancer
The FDA has expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva) with BCG to treat adults with BCG-unresponsive, high-grade...
FDA Expands Pirtobrutinib Approval to First-Line CLL/SLL
The FDA has approved pirtobrutinib (Jaypirca) for first-line treatment of adults with previously untreated chronic lymphocytic leukemia or small...
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 cancer treatment
The FDA granted accelerated approval to AstraZeneca's camizestrant (Etcamah) for HR-positive, HER2-negative breast cancer patients with an ESR1...
Induced Proximity Therapies Gain Ground After First PROTAC Approval
The first FDA-approved PROTAC drug for breast cancer has validated a new class of medicines that work by bringing proteins together.
Ionis' Zanvastro Wins First FDA Approval for Alexander Disease
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.
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...
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...