Approved – Page 5

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

3 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

FDA Approves Novavax COVID Vaccine After Delay, Limits Use to Smaller High-Risk Population

3 months ago talkbio0Tagged Approved, COVID19 (disease), Elderly (population group), Health conditions:-:Point in time:^Patient:-, Novavax, Nuvaxovid, protein-based vaccine, restricted population, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; Nuvaxovid; restricted population; protein-based vaccine; older adults; underlying health conditions

Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost

3 months ago talkbio0Tagged Adoption, Alzheimer 's disease, Approved, AutoInjector, Biogen, dosing, Eisai, Hematologic Tests, launch, Leqembi, Maintenance, Market, subcutaneous, United States Food and Drug Administration

Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption

Pfizer-backed CellCentric Secures $120M for Myeloma Drug Trials

3 months ago talkbio0Tagged Accelerated, Approved, CellCentric, Clinical Trials, Inobrodib, Multiple Myeloma, oral drug, p300/CBP inhibitor, Pfizer, Series C

CellCentric; Pfizer; multiple myeloma; Series C funding; inobrodib; p300/CBP inhibitor; oral drug; clinical trials; phase 2/3; accelerated approval

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

3 months ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

3 months ago talkbio0Tagged AbbVie, Accelerated, ADC, Approved, Emrelis, Malignant neoplasm of lung, MET protein, human, Non-Small Cell Lung Carcinoma, Protein Overexpression, Solid Neoplasm, Telisotuzumab, therapeutic autologous dendritic cells, United States Food and Drug Administration, vedotin-tllv

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis

4 months ago talkbio0Tagged Approved, DTC Campaign, Empowerment, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, self-administration, Syringes, United States Food and Drug Administration, Vyvgart Hytrulo

Vyvgart Hytrulo, prefilled syringe, FDA approval, self-administration, generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), DTC campaign, patient empowerment