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Latest posts
Last updated 1 day ago
Artificial Intelligence for Drug Development
1 day ago
FDA recognizes the increased use of AI throughout the drug development process...
External Engagements with FDA for Artificial Intelligence in Drug Development
1 day 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
2 days 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
2 days 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
2 days ago
FDA is announcing that it issued a “safe to proceed” letter to...
Ongoing | Cancer Accelerated Approvals
2 days ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Drug Trials Snapshot: TRYNGOLZA
2 days ago
TRYNGOLZA is a prescription medicine (an APOC-III-directed antisense oligonucleotide) that is used...
Drug Trials Snapshot: ALYFTREK
2 days ago
ALYFTREK is a medication for the treatment of cystic fibrosis (CF) in...
Drug Trials Snapshot: ROMVIMZA
2 days ago
The FDA approved ROMVIMZA based on safety and efficacy evidence from one...
Drug Trials Snapshots: QFITLIA
2 days ago
QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis...
Drug Trials Snapshot: VANRAFIA
2 days ago
VANRAFIA is an endothelin type A receptor antagonist that is indicated to...