FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics…
FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation…
Melanoma brain metastasis occurs when tumor cells hijack an inflammatory pathway in the brain and blocking this pathway could prevent…
FDA Announces Availability of Draft Guidance – Drug Master Files — Read on s2027422842.t.en25.com/e/es
“The efficacy of ceritinib was evaluated in patients who have ALK-positive non-small cell lung cancer with active brain metastases.” —…
The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine…
In people with pancreatic cancer, the composition of their tumor microbiome might predict how long they live, according to a…
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…