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 North Carolina 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 ...
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.
Kendric Cromer is the first patient in the U.S. to undergo a newly approved gene therapy for sickle cell disease.
Philadelphia is home to nearly 10 percent of the world’s cell and gene therapy companies, employing about 7,000 people, ...
The agency is slated to decide in November whether to approve the PI3Kα inhibitor as a first-line option for PIK3CA-mutated advanced breast cancer.
Smoking is a major driver for bladder cancer. Now, a new treatment has come to Philadelphia to help more patients maintain ...
Hemophilia B patients given Beqvez had a decreased incidence of total bleeding Beqvez reduced the use of routine factor IX ...
In an important step toward more effective gene therapies for brain diseases, researchers from the Broad Institute of MIT and Harvard have engineered a gene-delivery vehicle that uses a human protein ...
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 ...
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.