Qualitative Concept – Page 2

FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

3 weeks ago talkbio0Tagged Clinical Trials, Invasive, Malignant neoplasm of urinary bladder, mitomycin, Non-Muscle, Oncologic Drugs Advisory Committee, Pharma, RCT, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen

FDA; UroGen Pharma; UGN-102; bladder cancer; Oncologic Drugs Advisory Committee; mitomycin; RCT; non–muscle invasive bladder cancer; clinical trials

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

3 weeks 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 weeks 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 weeks 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 weeks 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

Mayne Pharma Faces FDA Action Over ‘Misleading’ Drug Safety Claims Ahead of $430M Buyout

3 weeks ago talkbio0Tagged Claims, Contraceptives, Oral, Cosette Pharmaceuticals, drug safety, Mayne, Nextstellis, Pharma, United States Food and Drug Administration

Mayne Pharma; FDA; misleading claims; Nextstellis; birth control pill; drug safety; buyout; Cosette Pharmaceuticals

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

3 weeks 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

Roche injects $550M into Indianapolis hub to scale up CGM production

4 weeks ago talkbio0Tagged Continuous glucose monitoring, Indianapolis, Investments, Manufacture, production, Roche (company), United States

Indianapolis, Roche (company), Continuous glucose monitoring, production, Manufacture, Investments, United States

Trump signs sweeping executive order to cut US drug prices by ‘up to 90%’

4 weeks ago talkbio0Tagged HHS, Policy, Prices, Transplant Registry Unified Management Program, United States

Prices, HHS, United States, Transplant Registry Unified Management Program, Policy

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

1 month 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