United States Food and Drug Administration – Page 8

Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease

2 months ago talkbio0Tagged Abeona, Abeona 's, Approved, Dermatologic disorders, gene therapy, Hallopeau-Siemens Disease, Infrequent, United States Food and Drug Administration, ZEVASKYN

United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s

FDA decision on Stealth’s Barth syndrome drug delayed, again

2 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Decision, Elamipretide, United States Food and Drug Administration

United States Food and Drug Administration, 3-Methylglutaconic aciduria type 2, Decision, Elamipretide

FDA approves Abeonas skin disease cell therapy

2 months ago talkbio0Tagged Abeona, Approved, gene therapy, Hallopeau-Siemens Disease, Treating, United States Food and Drug Administration, Wounds - qualifier, ZEVASKYN

ZEVASKYN, United States Food and Drug Administration, Hallopeau-Siemens Disease, Approved, Wounds – qualifier, gene therapy, Abeona, Treating

Biohaven, after setbacks, sees shares jump with Oberland Capital funding agreement worth up to $600M

2 months ago talkbio0Tagged Approved, Ataxia, Spinocerebellar, Capital, Investments, non-dilutive, Note (document), secured, United States Food and Drug Administration

Biohaven, Oberland Capital, $600 million investment, troriluzole, spinocerebellar ataxia (SCA), non-dilutive funding, FDA approval, senior secured notes

J&J reports durability data for bladder cancer ‘pretzel’ drug after FDA filing

2 months ago talkbio0Tagged Malignant neoplasm of urinary bladder, TAR 200, United States Food and Drug Administration, Urinary Bladder

Urinary Bladder, TAR 200, United States Food and Drug Administration, Malignant neoplasm of urinary bladder

Akeso’s PD-1 inhibitor notches inaugural FDA nod for nasopharyngeal cancer

2 months ago talkbio0Tagged Akeso, Akeso 's, Anniko, Approved, Inhibitor, Nasopharyngeal carcinoma, PDCD1 gene, United States Food and Drug Administration

United States Food and Drug Administration, Approved, Akeso, Nasopharyngeal carcinoma, PDCD1 gene, Inhibitor, Akeso ‘s, Anniko

Caribou cuts 32% of staff, further purges pipeline to focus on 2 oncology CAR-T prospects

2 months ago talkbio0Tagged 32%, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, CAR-T, Cell Therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, Neoplasms, Reindeer, Staff, United States Food and Drug Administration

Reindeer, CAR-T, Staff, Neoplasms, Cell Therapy, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, United States Food and Drug Administration, 32%