Temporal Concept – Page 27

FDA Grants First Approval for Orchard Therapeutics’ Gene Therapy Lenmeldy in Treating Rare Pediatric Neuron Disease

1 year ago talkbio0Tagged Approved, Autologous Gene Therapy, Infantile/, Juvenile, Lenmeldy, Leukodystrophy, Metachromatic, Orchard, Pre-Symptomatic Late, Rare Pediatric Disease, United States Food and Drug Administration

Orchard Therapeutics, Lenmeldy, FDA Approval, Metachromatic Leukodystrophy (MLD), Rare Pediatric Disease, Autologous Gene Therapy, Pre-Symptomatic Late Infantile/ Early Juvenile Patients

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.

MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)

1 year ago talkbio0Tagged AbbVie, ADAM9 protein, human, Anti-ADAM9 ADC IMGC936, Effectiveness, issues, MacroGenics, Partnered ADC, Safety Concerns

MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues

FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment

1 year ago talkbio0Tagged cisplatin, Combined, Opdivo, Overall Survival

Overall Survival, Combined, cisplatin, Opdivo

Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

1 year ago talkbio0Tagged Accelerated, Approved, broadest label, Brukinsa, BTK Inhibitor, CHMP, Chronic lymphoma, Combined Modality Therapy, Lymphoma, Follicular, obinutuzumab, Oregon (geographic location), Overall response rate, Phase 2 Clinical Trials, Phase II ROSEWOOD trial, Recommendation, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Relapsing course, Rosewood, United States Food and Drug Administration

Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR

Boundless Bio, Oncology Startup Targeting Extrachromosomal DNA, Files for $100 Million IPO

1 year ago talkbio0Tagged Arch of foot, Backed, Bayer, bleomycin/dacarbazine/lomustine/vincristine, Boundless, Checkpoint Kinase 1 Inhibitors, extrachromosomal DNA, IPO, Nasdaq Listing, Oncology Startup, Partner in relationship, Phase 1 Trials, Preliminary, Public Offering, Second Half of 2024, small molecule drugs, symbol

Boundless Bio, Oncology Startup, Initial Public Offering (IPO), Extrachromosomal DNA (ecDNA), Small Molecule Drugs (ecDTx), Checkpoint Kinase 1 Inhibitors, Phase 1 Trials, Nasdaq Listing (Symbol: BOLD), Backed by Bayer and Arch Venture Partners, Preliminary Data Expected in Second Half of 2024

Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update

1 year ago talkbio0Tagged Analog, Antibody-Drug, Efruxifermin, fibroblast growth factor 21, Fibrosis Response Rate, Improvements, metabolic dysfunction-associated steatohepatitis, Phase IIb HARMONY Study, Statistical Significance

Akero Therapeutics, FGF21 Analog, efruxifermin (EFX), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Phase IIb HARMONY Study, Fibrosis Response Rate, 96 Weeks, Statistically Significant Improvements