The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Chimerix (CMRX) announced the FDA has accepted its New Drug Application, or NDA, seeking accelerated approval for dordaviprone as a treatment ...
There is no approved therapeutic option for treating ... Biodexa, which has already received U.S. FDA Orphan Drug designation for eRapa in FAP, plans to seek a similar designation in Europe.
FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
This approval marks another significant step forward ... by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in 2017. In 2021, ...
The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology.
Stamford-based SpringWorks Therapeutics, a commercial-stage biotech company developing treatments for rare diseases and ...
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
The kinase inhibitor is now approved for adults and children aged ≥ 2 years with neurofibromatosis type 1 who have ...
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