Tag Archive for: regulatory approval

Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.

The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease —amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving.

The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.

The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA’s approval was based on trials which extended median progression-free survival (PFS) by nearly nine months.

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 […]

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.