Approved – Page 2

Parkinson’s Patients Prefer Medtronic’s Adaptive Brain Stimulation Over Traditional Settings, Major Study Shows

4 weeks ago talkbio0Tagged ADAPT-PD study, adaptive deep brain stimulation, aDBS, Approved, Deep Brain Stimulation, Medtronic, Parkinson 's disease, personalized neuromodulation, real-time brain monitoring, United States Food and Drug Administration

Parkinson’s disease; adaptive deep brain stimulation; aDBS; Medtronic; ADAPT-PD study; FDA approval; DBS; personalized neuromodulation; real-time brain monitoring

FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay

4 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Abnormality of mitochondrial metabolism, Accelerated, Approved, Elamipretide, Forzinity, Infrequent, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval

FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome

4 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Clinical Trials, Elamipretide, Forzinity, Infrequent, Mitochondrial Diseases, Pediatric Disorder, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial

Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach

4 weeks ago talkbio0Tagged Approved, Biosimilars, checkpoint inhibitors, Immunotherapy for cancer, Keytruda, Keytruda Qlex, Merck, patent expiration, Solid Neoplasm, Subcutaneous Injections, United States Food and Drug Administration

Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy

Novo Nordisk Awaits FDA Decision on Oral Wegovy Pill for Obesity

1 month ago talkbio0Tagged Approved, Cardiovascular Risk, Contraceptives, Oral, Glucagon-Like Peptide 1, Nordisk, Obesity, oral semaglutide, United States Food and Drug Administration, Wegovy, Weight Loss

Novo Nordisk; Wegovy; oral semaglutide; FDA approval; obesity treatment; GLP-1 pill; weight loss; cardiovascular risk

Next-Generation Psoriasis Drugs Aim to Reshape Treatment Landscape

1 month ago talkbio0Tagged Approved, Clinical Trials, icotrokinra, inhibitors, interleukin-23, next-generation biologics, oral peptides, Piclidenoson, TYK2 gene, United States Food and Drug Administration, Vunakizumab

psoriasis; next-generation biologics; icotrokinra; IL-23 inhibitors; oral peptides; TYK2 inhibitors; vunakizumab; piclidenoson; clinical trials; FDA approval

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

1 month ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

1 month ago talkbio0Tagged Approved, BCG-Unresponsive, Carcinoma, Drug Delivery Systems, gemcitabine intravesical system, in situ, Inlexzo, Johnson & Johnson, Malignant neoplasm of urinary bladder, New, Non-Muscle Invasive Bladder Neoplasms, SunRISe-1 trial, United States Food and Drug Administration

Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ