Qualitative Concept
Spotlight on LGBTQ+ Leaders Driving Change in Life Sciences
LGBTQ+ professionals; life sciences; biopharma; leadership; Diversity and Inclusion; Health Workforce; GUTC Fellows; philanthropy; Pride Month
Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application
Moderna; mRNA-1083; combination vaccine; flu; COVID-19; FDA; Biologics License Application; vaccine efficacy; clinical trial; share price
FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies
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
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
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
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
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
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
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
Indianapolis, Roche (company), Continuous glucose monitoring, production, Manufacture, Investments, United States