US FDA grants accelerated approval for Iovance’s skin cancer cell therapy Feb 16 (Reuters) – Iovance Biotherapeutics (IOVA.O) said on Friday the U.S. health regulator has granted an accelerated approval for its […]
Tag Archive for: regulatory approval
The agency approved the use of Regeneron and Sanofi’s Dupixent to treat an allergic inflammation of the esophagus in children aged one to 11 years old and weighing at least 15 kg.
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The FDA’s decision further pushes the timeline for Shin Nippon to enter a crowded U.S. market for migraine drugs that include treatments from Pfizer, Abbvie, and Eli Lilly.
The announcement comes just a month after Casgey was approved by the FDA in December 2023 to treat patients with sickle cell disease, when it became the first CRISPR gene editing therapy to reach the U.S. market.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
This approval marks the third indication for Keytruda in cervical cancer and the 39th indication for Keytruda in the United States.
2023 was a breakthrough year for cell and gene therapies, with seven FDA approvals in the U.S. and one in the European Union, according to the Alliance for Regenerative Medicine. Looking to 2024, the Washington, D.C.–based advocacy organization predicted that the sector could see up to 17 approvals in the U.S. and EU.
The two companies are preparing to launch the drug in the second quarter of Eisai’s 2024/25 business year starting in April.
Today the company announced that Canada’s health regulator approved its gene therapy for the treatment of a rare inherited bleeding disorder called hemophilia B ahead of a U.S. decision.
