United States Food and Drug Administration – Page 8

FDA Approves Ono’s Romvimza for Rare Joint Tumor, Challenging Daiichi Sankyo’s Turalio

2 months ago talkbio0Tagged Approved, CSF1, CSF1 gene, Daiichi, Dosage Forms, Fibrous histiocytoma of tendon sheath, Giant Cell Tumors, Inhibitor, Joint Tumor, Romvimza, Sankyo, tenosynovial, Turalio, United States Food and Drug Administration, Vimseltinib

Romvimza, vimseltinib, tenosynovial giant cell tumor (TGCT), Ono Pharmaceutical, FDA approval, Daiichi Sankyo, Turalio, CSF1 inhibitor, rare joint tumor

GSK’s Penmenvy Gains FDA Approval, Joining Pfizer in 5-in-1 Meningococcal Vaccine Market

2 months ago talkbio0Tagged Adolescent (age group), Approved, Invasive meningococcal disease, Meningococcal vaccine, Penmenvy, Pfizer, SmithKline Beecham, United States Food and Drug Administration, Vaccines, Young Adult

Penmenvy, GSK, FDA approval, meningococcal vaccine, 5-in-1 vaccine, Pfizer, Penbraya, invasive meningococcal disease (IMD), adolescents and young adults

Massive Layoffs Sweep Federal Health Agencies: Thousands of Workers Impacted Across HHS

2 months ago talkbio0Tagged Administration occupational activities, Centers for Disease Control and Prevention (U.S.), federal, Health agencies, HHS layoffs, Myasthenic Syndromes, Congenital, NIH, NIH Mouse, probationary workers, Transplant Registry Unified Management Program, United States Food and Drug Administration

HHS layoffs, federal health agencies, probationary workers, Trump administration, workforce reduction, CDC, NIH, FDA, CMS

Mass Layoffs at HHS: Trump Administration Cuts Thousands of Probationary Workers

2 months ago talkbio0Tagged Administration occupational activities, Centers for Disease Control and Prevention (U.S.), HHS layoffs, NIH Mouse, public health medicine (field), Transplant Registry Unified Management Program, United States Food and Drug Administration, Workers

HHS layoffs, probationary employees, Trump administration, CDC, NIH, FDA, federal workforce reduction, public health impact

FDA Approves Extended Dosing for Astellas’ Izervay, Intensifying Competition in Geographic Atrophy Treatment

2 months ago talkbio0Tagged Age related macular degeneration, Apellis, Approved, Astellas, dosing, Extension, eye treatment, Geographic Atrophy, IZERVAY, Syfovre, United States Food and Drug Administration

Izervay, Astellas, FDA approval, extended dosing, geographic atrophy, age-related macular degeneration, Syfovre, Apellis, eye treatment

FDA Approves Pfizer’s Adcetris Combination Therapy for Relapsed/Refractory Large B-cell Lymphoma

2 months ago talkbio0Tagged Adcetris, Antibody-Drug Conjugates, Approved, BRENTUXIMAB, Combined Modality Therapy, Diffuse Large B-Cell Lymphoma, LBCL, Pfizer, United States Food and Drug Administration, vedotin

Adcetris, brentuximab vedotin, FDA approval, large B-cell lymphoma, LBCL, DLBCL, antibody-drug conjugate, Pfizer, combination therapy

FDA Approves Extended Dosing for Astellas’ Izervay in Geographic Atrophy Treatment

2 months ago talkbio0Tagged Age related macular degeneration, Approved, Astellas, avacincaptad, dosing, Extension, Geographic Atrophy, IZERVAY, pegol, Pharma, United States Food and Drug Administration

Izervay, avacincaptad pegol, geographic atrophy, age-related macular degeneration, FDA approval, extended dosing, Astellas Pharma

FDA Approves Evrysdi Tablets: A Breakthrough in Convenient SMA Treatment

2 months ago talkbio0Tagged Approved, Drug Formulation Process, Evrysdi, genentech, Oral treatment, Risdiplam, Roche (company), Spinal Muscular Atrophy, Tablet Dosage Form, United States Food and Drug Administration

Evrysdi, risdiplam, spinal muscular atrophy (SMA), FDA approval, tablet formulation, oral treatment, Genentech, Roche

SpringWorks Therapeutics Secures FDA Approval for Gomekli to Treat NF1-Related Tumors

2 months ago talkbio0Tagged Approved, disease treatment, Gomekli, Infrequent, Inhibitor, MEK, mirdametinib, Neurofibromatosis 1, Plexiform, Plexiform Neurofibroma, SpringWorks, United States Food and Drug Administration

SpringWorks Therapeutics, Gomekli, mirdametinib, FDA approval, neurofibromatosis type 1 (NF1), plexiform neurofibromas (PN), rare disease treatment, MEK inhibitor

Gilead Sciences Prepares for Summer 2025 Launch of Long-Acting HIV Prevention Drug Lenacapavir

2 months ago talkbio0Tagged Approved, Clinical Trials, Gilead Sciences, HIV Prevention, HIV sales, Lenacapavir, PREP gene, PURPOSE studies, United States Food and Drug Administration

Gilead Sciences, lenacapavir, HIV prevention, PrEP, long-acting injectable, FDA approval, HIV sales, clinical trials, PURPOSE studies