Approved – Talk Bio

Replimune Resubmits Melanoma Drug for FDA Approval After Initial Rejection

17 hours ago talkbio0Tagged Approved, melanoma, Replimune, resubmission, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; Melanoma Treatment; FDA Approval; Resubmission

Achieve Life Sciences Appoints Erik Atkisson as Chief Legal Officer

1 day ago talkbio0Tagged Achieve Life Sciences, Approved, Chief Legal Officer, cytisine, Erik Atkisson, United States Food and Drug Administration

Achieve Life Sciences; Erik Atkisson; Chief Legal Officer; Cytisinicline; FDA Approval

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

1 week ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

1 week ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

2 weeks ago talkbio0Tagged Approved, Boehringer Ingelheim, Chronic lung disease, Idiopathic Pulmonary Fibrosis, Jascayd, lung scarring, nerandomilast, Pulmonary Fibrosis, United States Food and Drug Administration

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

3 weeks ago talkbio0Tagged amgen, Approved, Cardiovascular Diseases, Cardiovascular event, Cerebrovascular accident, LDL-C, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, United States Food and Drug Administration, VESALIUS-CV trial

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke

Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives

3 weeks ago talkbio0Tagged Approved, Bruton 's tyrosine kinase inhibitor, BTKi, chronic hives, Chronic Spontaneous Urticaria, competition, Immunology, Novartis, Oral Therapy, remibrutinib, Rhapsido, United States Food and Drug Administration

Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition

Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

3 weeks ago talkbio0Tagged activin signaling, AKAP9 protein, human, Approved, Clinical Research, clinical worsening, early disease, Merck, PAH, Phase 3 trial, Sotatercept, United States Food and Drug Administration, Winrevair

Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial

Eli Lilly’s Oral SERD Inluriyo Approved by FDA for ESR1-Mutated Breast Cancer

4 weeks ago talkbio0Tagged Approved, Carcinoma breast stage IV, Eli, Eli Lilly, EMBER-3 trial, ESR1 gene, Estrogen receptor positive, HER2-negative, Imlunestrant, Inluriyo, Mutation, Oral SERD, United States Food and Drug Administration

Eli Lilly; Inluriyo; oral SERD; imlunestrant; FDA approval; ESR1 mutation; metastatic breast cancer; estrogen receptor positive; HER2-negative; EMBER-3 trial

uniQure’s Gene Therapy AMT-130 Significantly Slows Huntington’s Progression in Pivotal Trial

4 weeks ago talkbio0Tagged AMT-130, Approved, Clinical Trials, Disease Progression, gene therapy, huntingtin-lowering, Huntington 's disease, Nerve Degeneration, UniQure, United States Food and Drug Administration

Gene therapy; uniQure; AMT-130; Huntington’s disease; clinical trial; disease progression; FDA approval; huntingtin-lowering; neurodegeneration