United States Food and Drug Administration – Page 82

Neumora Therapeutics’ Schizophrenia Drug NMRA-266 Faces FDA Hold Over Convulsions in Rabbits

2 years ago talkbio0Tagged Neumora, NMRA-266, Schizophrenia, Seizures, United States Food and Drug Administration

Neumora, United States Food and Drug Administration, NMRA-266, Seizures, Schizophrenia

AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11

2 years ago talkbio0Tagged Age, Approved, AstraZeneca, benralizumab, Child, expansion, Fasenra, Pediatric Label, Severe asthma, United States Food and Drug Administration

AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11

FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS

2 years ago talkbio0Tagged Agreement, Amyotrophic Lateral Sclerosis, BrainStorm Cell Therapeutics, Early-stage, NurOwn, SPA, Special Protocol Assessment, Trial Phase 3B, United States Food and Drug Administration

BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)

AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy

2 years ago talkbio0Tagged Accelerated Approval, Approved, AstraZeneca, Daiichi Sankyo, DESTINY-PanTumor02 Study, Enhertu, HER2-directed therapy, Metastatic HER2-Positive Solid Tumors, Objective Response Rate, ORR, Response Duration, tumor-agnostic, United States Food and Drug Administration

Enhertu, AstraZeneca, Daiichi Sankyo, FDA Approval, Tumor-Agnostic, HER2-Directed Therapy, Metastatic HER2-Positive Solid Tumors, Accelerated Approval, DESTINY-PanTumor02 Study, Objective Response Rate (ORR), Duration of Response (DoR)

FDA Oncology Chief Emphasizes Equitable Standards in Confirmatory Trial Rejections at AACR24

2 years ago talkbio0Tagged AACR24, Confirmatory Trial Rejection, Level Playing Field, Oncology Chief, Pazdur, Project, United States Food and Drug Administration

AACR24, FDA Oncology Chief, Richard Pazdur, Confirmatory Trial Rejection, Level Playing Field, Project

Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections

2 years ago talkbio0Tagged ABSSSI, Acute bacterial skin, Approved, Bacteremia due to Staphylococcus aureus, Basilea Pharmaceutica, CABP, ceftobiprole, Community-acquired bacterial pneumonia, designations, exclusivity, Priority Review, QIDP, Qualified Infectious Disease Product, skin structure infections, Track/, United States Food and Drug Administration, year, Zevtera

Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US

Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder

2 years ago talkbio0Tagged acute, Bipolar I disorder, Dentatorubral-Pallidoluysian Atrophy, Fanapt, iloperidone, Manic, mixed episodes, United States Food and Drug Administration, Vanda Pharmaceuticals

Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

2 years ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

2 years ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data

Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial

2 years ago talkbio0Tagged Antibody/, Approval/, Disease/, Inclacumab/, monoclonal, Pfizer/, Program/, terminated - RoleStatus, Thrive, Trial/ Poor Accrual, United States Food and Drug Administration

Pfizer/ Sickle Cell Disease/ FDA Approval/ Inclacumab/ THRIVE Program/ Monoclonal Antibody/ Terminated Trial/ Poor Accrual