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Latest posts
Last updated about 15 hours ago
Artificial Intelligence for Drug Development
about 16 hours ago
FDA recognizes the increased use of AI throughout the drug development process...
External Engagements with FDA for Artificial Intelligence in Drug Development
about 16 hours ago
To discuss the use of AI in connection with a specific development...
FDA works to protect consumers from potentially harmful OTC skin lightening products
about 18 hours ago
FDA works to protect consumers from potentially harmful OTC skin lightening products
FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
about 20 hours ago
FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
about 20 hours ago
FDA is announcing that it issued a “safe to proceed” letter to...
Ongoing | Cancer Accelerated Approvals
about 22 hours ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Drug Trials Snapshot: TRYNGOLZA
about 22 hours ago
TRYNGOLZA is a prescription medicine (an APOC-III-directed antisense oligonucleotide) that is used...
Drug Trials Snapshot: ALYFTREK
about 22 hours ago
ALYFTREK is a medication for the treatment of cystic fibrosis (CF) in...
Drug Trials Snapshot: ROMVIMZA
about 23 hours ago
The FDA approved ROMVIMZA based on safety and efficacy evidence from one...
Drug Trials Snapshots: QFITLIA
about 23 hours ago
QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis...
Drug Trials Snapshot: VANRAFIA
about 23 hours ago
VANRAFIA is an endothelin type A receptor antagonist that is indicated to...