United States Food and Drug Administration
AbbVie’s Skyrizi Secures Key FDA Approval for Ulcerative Colitis Treatment
Skyrizi, AbbVie, FDA approval, ulcerative colitis, inflammatory bowel disease, IL-23 inhibitor, Crohn’s disease
Amgen’s Blincyto Wins FDA Approval for Expanded Leukemia Use
Blincyto, Amgen, FDA Approval, Leukemia Treatment, Minimal Residual Disease (MRD), Acute Lymphoblastic Leukemia (ALL), Bispecific Antibody
PTC Therapeutics Reports Positive Phase II Huntington’s Disease Data, FDA Lifts Partial Clinical Hold
PTC Therapeutics, Huntington’s disease, Phase II data, FDA, partial clinical hold, PTC518, mutant huntingtin protein, clinical trends, safety, tolerability.
FDA Approves Keytruda for Primary Advanced or Recurrent Endometrial Carcinoma and Skyrizi for Ulcerative Colitis
Keytruda, pembrolizumab, endometrial carcinoma, Skyrizi, risankizumab-rzaa, ulcerative colitis, FDA approval
FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths
Zentalis Pharmaceuticals, azenosertib, FDA, partial clinical hold, cancer studies, sepsis deaths, WEE1 inhibitor, clinical trials, patient safety
Caplyta Achieves Significant Victory in Major Depressive Disorder Trial, Paving Way for Competition with Vraylar
Caplyta, lumateperone, Intra-Cellular Therapies, major depressive disorder, MDD, Vraylar, AbbVie, antipsychotic, adjunctive therapy, FDA approval, clinical trials
Merck’s Capvaxive: FDA Approves First Pneumococcal Vaccine Designed for Adults
Merck, Capvaxive, FDA Approval, Pneumococcal Vaccine, Adults, Pneumonia, Invasive Pneumococcal Disease
FDA Approves Pembrolizumab and Durvalumab for Endometrial Cancer Treatment
FDA, Pembrolizumab, Durvalumab, Endometrial Cancer, Immunotherapy, Chemotherapy
AstraZeneca’s IMFINZI Plus Chemotherapy Approved in the US for Mismatch Repair Deficient Endometrial Cancer
IMFINZI, durvalumab, endometrial cancer, mismatch repair deficient, chemotherapy, AstraZeneca, FDA approval
Ipsen and Genfit Secure FDA Approval for Iqirvo, a Breakthrough Treatment for Primary Biliary Cholangitis
Ipsen, Genfit, Iqirvo, FDA approval, primary biliary cholangitis, liver disease, Intercept, Ocaliva