1.https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/ 2. U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for ...
One of the major gene therapy developers to watch in 2022 is bluebird bio. The company has two gene therapies which are expecting FDA approval this year. Betibeglogene autotemcel (beti-cel) is a cell-based gene therapy comprising autologous CD34+ hematopoietic stem cells (HSCs) transduced ex ...
[1] FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy. Retrieved March 18, 2024 from https://www.prnewswire.com/news-releases/fda-approves-first-gene-therapy-for-children-with-metachromatic-leukodystrophy-302091811.html [2] Orchard Therapeutics Announces Acceptance of Biologi...
therapy. Nadofaragene firadenovec comprises a recombinant adenovirus vector harboring the human interferon alpha 2b gene, administered once every 3 months intravesically in combination with excipient Syn3 to enhance transduction ...
2023年美国FDA没有批准任何一个CAR-T药物及治疗癌症的ADC药物。加上2022年美国FDA批准的两个治疗癌症的动用T细胞的双抗药物,双抗药物、ADC药物、及以CAR-T为代表的细胞治疗药物正在形成癌症治疗药物的三驾马车。 2023年美国FDA共批准了Veopoz、Bimzelx、Omvoh、Rystiggo四个免疫抑制剂生物药,维持了自体免疫领域的...
[5]https://www.prnewswire.com/news-releases/fda-approves-first-cellular-therapy-to-treat-patients-with-type-1-diabetes-301866374.html [6]https://www.prnewswire.com/news-releases/fda-approves-cell-therapy-for-patients-with-blood-cancers-to-reduce-risk-of-infection-following-stem-cell-transplantati...
[6]https://www.prnewswire.com/news-releases/fda-approves-cell-therapy-for-patients-with-blood-cancers-to-reduce-risk-of-infection-following-stem-cell-transplantation-301799198.html [7]https://investors.biomarin.com/2023-06-29-U-S-Food-and-Drug-Administration-Approves-BioMarins-ROCTAVIAN-TM-va...
T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma. Retrieved May 30, 2024 from https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-as-a-New-CAR-T-Cell-Therapy-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx...
eligible for surgery, and tumors can recur, even after the procedure," said Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval is the first FDA-approved therapy to treat this rare disease....
Dec 20, 2024, 16:32 ET FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound...