Approved – Page 2

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

3 weeks ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

3 weeks ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

3 weeks ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

Merck Reports Pivotal PCSK9 Pill Data in Race to Beat AstraZeneca to Market

4 weeks ago talkbio0Tagged Approved, AstraZeneca, Autoimmune hemolytic anemia, Cardiovascular Diseases, CORALreef trial, enlicitide, LDL-C, Merck, oral cholesterol pill, PCSK9 inhibitor, United States Food and Drug Administration

Merck; PCSK9 inhibitor; enlicitide; oral cholesterol pill; AstraZeneca; CORALreef trial; LDL-C reduction; AHA 2025; FDA approval; cardiovascular disease

Pfizer Triumphs Over Novo Nordisk with $10B Bid to Acquire Metsera

4 weeks ago talkbio0Tagged Acquisition, Approved, bidding war, Drug Industry, Glucagon-Like Peptide 1, Metsera, Nordisk, Obesity, Pfizer, shareholder

Pfizer; Novo Nordisk; Metsera; obesity drugs; GLP-1; acquisition; bidding war; shareholder approval; pharmaceutical industry

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

4 weeks ago talkbio0Tagged Approved, AQUILA study, daratumumab, Darzalex Faspro, Early Intervention (Education), high-risk, Progression-Free Survival, Smoldering myeloma, United States Food and Drug Administration

FDA approval; Darzalex Faspro; high-risk smoldering multiple myeloma; AQUILA study; early intervention; progression-free survival; daratumumab; hyaluronidase-fihj

Sarepta’s Duchenne Muscular Dystrophy Drugs Fail Confirmatory Trial, Company Pursues Full FDA Approval Regardless

1 month ago talkbio0Tagged Accelerated, AMONDYS, Approved, Clinical trial failure, Confirmatory Trial, ELEVIDYS, Muscular Dystrophy, Duchenne, Statistical Significance, United States Food and Drug Administration

Sarepta Therapeutics; Duchenne muscular dystrophy; confirmatory trial; AMONDYS 45; VYONDYS 53; Elevidys; FDA approval; clinical trial failure; accelerated approval; statistical significance

UCB Wins First FDA Approval for Ultra-Rare Mitochondrial Disease: Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

1 month ago talkbio0Tagged Approved, Breakthrough Therapy, doxecitine, doxribtimine, Drugs, Orphan, Infrequent, Kygevvi, Mitochondrial Diseases, Pediatric Disorder, Priority Review, Thymidine kinase 2 deficiency, TK2d, UCB, United States Food and Drug Administration

UCB; FDA approval; Kygevvi; mitochondrial disease; Thymidine Kinase 2 deficiency; TK2d; doxecitine; doxribtimine; rare diseases; Orphan Drug; Breakthrough Therapy; Priority Review; Rare Pediatric Disease

uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy

1 month ago talkbio0Tagged Accelerated, AMT-130, Approved, Clinical Trials, gene therapy, Huntington 's disease, Regulatory Setback, UniQure, United States Food and Drug Administration

uniQure; AMT-130; Huntington’s disease; gene therapy; FDA; accelerated approval; regulatory setback; clinical trial

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

1 month ago talkbio0Tagged Accelerated, Approved, Biological Markers, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, Effectiveness, Functional improvement, Muscular Dystrophy, Duchenne, regulatory approval, z-rostudirsen

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval