Approved – Talk Bio

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

6 days 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

7 days 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

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

1 week ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology

LB Pharmaceuticals Raises $285M in Upsized IPO to Fund Late-Stage Schizophrenia Drug Development

1 week ago talkbio0Tagged amisulpride, Approved, Central Nervous System Agents, Depression, Bipolar, IPO, LB-102, Pounds, Schizophrenia, United States Food and Drug Administration

LB Pharmaceuticals; IPO; schizophrenia; LB-102; amisulpride; Phase 3 clinical trial; bipolar depression; biotech fundraising; CNS drugs; FDA approval

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

1 week ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

2 weeks ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

FDA Announces New Rare Disease Approval Programme

2 weeks ago talkbio0Tagged Accelerated, Approved, Biological Factors, conditional approval pathway, drug review, Endpoints, Infrequent, real-world data, streamlined process, Surrogate, United States Food and Drug Administration

FDA; rare disease; conditional approval pathway; accelerated approval; biologics; drug review; surrogate endpoints; real-world data; streamlined process