Approved – Page 29

Amgen’s Blincyto Wins FDA Approval for Expanded Leukemia Use

1 year ago talkbio0Tagged Acute lymphocytic leukemia, amgen, Antibodies, Bispecific, Approved, Blincyto, leukemia, MRD, Neoplasm, Residual, United States Food and Drug Administration

Blincyto, Amgen, FDA Approval, Leukemia Treatment, Minimal Residual Disease (MRD), Acute Lymphoblastic Leukemia (ALL), Bispecific Antibody

FDA Approves Keytruda for Primary Advanced or Recurrent Endometrial Carcinoma and Skyrizi for Ulcerative Colitis

1 year ago talkbio0Tagged Approved, Endometrial Carcinoma, Keytruda, pembrolizumab, risankizumab-rzaa, Ulcerative Colitis, United States Food and Drug Administration

Keytruda, pembrolizumab, endometrial carcinoma, Skyrizi, risankizumab-rzaa, ulcerative colitis, FDA approval

Caplyta Achieves Significant Victory in Major Depressive Disorder Trial, Paving Way for Competition with Vraylar

1 year ago talkbio0Tagged AbbVie, adjunctive therapy, Antipsychotic Agents, Approved, Caplyta, Clinical Trials, Depressive disorder, Intra-Cellular Therapies, Lumateperone, Major Depressive Disorder, United States Food and Drug Administration, 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

1 year ago talkbio0Tagged Adult, Approved, Capvaxive, Invasive Streptococcus pneumoniae disease, Merck, Pneumococcal vaccine, Pneumonia, United States Food and Drug Administration

Merck, Capvaxive, FDA Approval, Pneumococcal Vaccine, Adults, Pneumonia, Invasive Pneumococcal Disease

AstraZeneca’s IMFINZI Plus Chemotherapy Approved in the US for Mismatch Repair Deficient Endometrial Cancer

1 year ago talkbio0Tagged Approved, AstraZeneca, durvalumab, Imfinzi, Malignant neoplasm of endometrium, Mismatch Repair Deficiency, Pharmacotherapy, United States Food and Drug Administration

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

1 year ago talkbio0Tagged Approved, Biliary Cholangitis, Genfit, Intercept Substance, Ipsen, Iqirvo, Liver diseases, Ocaliva, United States Food and Drug Administration

Ipsen, Genfit, Iqirvo, FDA approval, primary biliary cholangitis, liver disease, Intercept, Ocaliva

GSK’s RSV Vaccine Wins Expected Expansion into At-Risk Adults Aged 50-59

1 year ago talkbio0Tagged Adult, Age, Approved, Arexvy, Asthma, Chronic Obstructive Airway Disease, Diabetes, Heart failure, Increased, medical conditions, Respiratory syncytial virus, Respiratory Tract Diseases, Risk, SmithKline Beecham, United States Food and Drug Administration, Vaccines

GSK, RSV vaccine, Arexvy, FDA approval, adults aged 50-59, increased risk, respiratory syncytial virus, lower respiratory tract disease, medical conditions, chronic obstructive pulmonary disease, asthma, heart failure, diabetes.