Rejection (Psychology)
Merck and Daiichi Sankyo’s ADC Pact Hits Regulatory Setback in FDA Rejection
Merck, Daiichi Sankyo, Antibody-Drug Conjugate (ADC), Patritumab Deruxtecan, FDA Rejection, Regulatory Setback, HER3 Protein, Non-Small Cell Lung Cancer (NSCLC)
AbbVie’s Duopa Successor in Parkinson’s Rejected Again Due to Third-Party Manufacturer Issues
AbbVie, Duopa, Parkinson’s disease, FDA rejection, third-party manufacturer, ABBV-951, carbidopa, levodopa, subcutaneous pump device
EU Upholds Approval of PTC Therapeutics’ Duchenne Muscular Dystrophy Treatment
EU, PTC Therapeutics, Duchenne Muscular Dystrophy (DMD), treatment, approval, rejection, committee.
FDA Rejects Elevar and Hengrui Pharma’s Combination Therapy for Liver Cancer
FDA, Elevar Therapeutics, Hengrui Pharmaceuticals, liver cancer, combination therapy, rejection, clinical trials.
FDA Rejects Hepatitis B Vaccine Update Due to Inadequate Documentation and Data
FDA, hepatitis B vaccine, vaccine update, document destruction, insufficient data, rejection
FDA Rejects Dynavax’s Heplisav-B Expansion Due to Data Gaps
FDA, Dynavax, Heplisav-B, data gaps, rejection, expansion, vaccine, hepatitis B
FDA Rejects Abeona’s PZ-CEL Topical Gene Therapy, Delaying Further Progress
Abeona, PZ-CEL, topical gene therapy, FDA, rejection, delay, clinical trials, EB-101, Epidermolysis Bullosa