Approved – Page 10

FDA Approves Evrysdi Tablets: A Breakthrough in Convenient SMA Treatment

7 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

7 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

7 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

FDA Approves SpringWorks’ Gomekli for Adult and Pediatric NF1-PN Patients

7 months ago talkbio0Tagged Approved, Gomekli, Inhibitor, MEK, mirdametinib, neurofibroma, Plexiform, SpringWorks, United States Food and Drug Administration

Gomekli, mirdametinib, neurofibromatosis type 1, plexiform neurofibromas, FDA approval, SpringWorks Therapeutics, MEK inhibitor

Vertex COO Stuart Arbuckle to Retire as Company Launches Groundbreaking Pain Drug Journavx

7 months ago talkbio0Tagged acute pain treatment, Approved, Arbuckle, Journavx, non-opioid pain medication, Retirement, Stuart Pharmaceuticals, United States Food and Drug Administration

Vertex Pharmaceuticals, Stuart Arbuckle, retirement, Journavx, non-opioid pain medication, FDA approval, acute pain treatment

Boehringer Ingelheim’s Nerandomilast Succeeds in Second Phase III Lung Fibrosis Trial, Paving Way for FDA Approval

7 months ago talkbio0Tagged Approved, Boehringer, FIBRONEER-ILD, fibrosing, Improvement, Ingelheim, Inhibitor, nerandomilast, PF-ILDs, Phase 3 Clinical Trials, phosphodiesterase 4B, Progressive, Respiratory physiology, United States Food and Drug Administration

Nerandomilast, Boehringer Ingelheim, Phase III trial, FIBRONEER-ILD, progressive fibrosing interstitial lung diseases (PF-ILDs), lung function improvement, FDA approval, phosphodiesterase 4B (PDE4B) inhibitor