Biogen’s injectable drug is for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S.
Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps patients.
Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients. That shortcut has come under increasing scrutiny from government watchdogs and congressional investigators. ALS patients hope the decision could lay the groundwork for more expedited approvals to fight the disease, which affects 16,000 to 32,000 people in the U.S. The FDA has long used accelerated approval to speed the availability of drugs for cancer and other deadly conditions.
Argentina Últimas Noticias, Argentina Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
FDA grants accelerated approval for Biogen ALS drug that treats rare form of the diseaseThe FDA's approval requires Biogen to further study its ALS drug tofersen to further verify its clinical benefits.
Leer más »
Foghorn Therapeutics stock slides 21% after FDA puts partial clinical hold on cancer drug trialFoghorn Therapeutics Inc.’s stock slid 21% in premarket trade Monday, after the biotech said the Food and Drug Administration has placed a partial hold on a...
Leer más »
Drug for rare form of Lou Gehrig’s disease OK'd by FDAU.S. health regulators have approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease
Leer más »
FDA Approves Drug for Rare Form of Lou Gehrig's DiseaseApproval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients.
Leer más »
FDA grants accelerated approval to Biogen’s treatment for rare form of ALSThe U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic...
Leer más »
FDA grants accelerated approval to Biogen treatment for rare form of ALSThe FDA has deemed Biogen's torferson reasonably likely to produce a clinical benefit for patients.
Leer más »