Qualitative Concept – Page 35

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

Voyager Therapeutics Halts ALS Gene Therapy Development Due to Off-Target Effects

7 months ago talkbio0Tagged Amyotrophic Lateral Sclerosis, Capsid, Cu-Zn Superoxide Dismutase, Drug Development, Effect, gene therapy, off-target, payload, Preclinical, RNA, Small Interfering, Tracer, VY9323

SOD1 ALS gene therapy, Off-target effects, VY9323, siRNA payload, TRACER capsid, Preclinical data, Drug development delay

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

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

7 months ago talkbio0Tagged alpha 1-antitrypsin, Chengdu, Chinese Language, Dosage Forms, Failed, import alert, innovation, Inspection (procedure), manufacturers, Quality, Science of Chemistry, United States Food and Drug Administration, Wuhu

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical

22 States Sue Trump Administration Over Drastic NIH Funding Cuts

7 months ago talkbio0Tagged Indirect, Medical Research activity, NIH Mouse, Research Projects, R-Series, Transplant Registry Unified Management Program, Universities

NIH funding, indirect costs, research grants, Trump administration, lawsuit, universities, medical research