Pfizer's first FDA-approved gene therapy is one of the most expensive medications in the U.S. On April 26, Beqvez (fidanacogene elaparvovec-dzkt) won approval to treat some adults with moderate-to ...
Pfizer's huge facility in Sanford produces its first FDA-approved gene therapy, which runs $3.5 million a dose. The U.S. Food and Drug Administration has approved a gene therapy developed by ...
But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two ...
Kendric Cromer is the first patient in the U.S. to undergo a newly approved gene therapy for sickle cell disease.
Gene therapy could potentially treat a range of severe genetic brain disorders, which currently have no cures and few treatment options. But FDA-approved forms of the most commonly used vehicle ...
Philadelphia is home to nearly 10 percent of the world’s cell and gene therapy companies, employing about 7,000 people, ...
Smoking is a major driver for bladder cancer. Now, a new treatment has come to Philadelphia to help more patients maintain ...
BE-101 involves engineering a patient's own B cells to insert a functional copy of the FIX gene, which is mutated in patients with hemophilia B.
Welcome to 2024's regulatory tracker for Fierce Pharma. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications.
Eladocagene exuparvovec is a one-time, recombinant adeno-associated virus serotype 2-based gene replacement therapy.
Agios Pharmaceuticals announced a $905 million purchase with Royalty Pharma —Pheon Therapeutics raised a $120 million Series ...