The FDA has granted orphan drug designation to the oral agent OPN-6602 for the treatment of patients with relapsed or ...
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FDA grants orphan drug status to Arbor Biotechnologies’ PH1The development comes after the US regulator granted approval for the investigational new drug ... “ABO-101 receiving rare ...
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 ...
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
US FDA accepts for priority review Sanofi & Regeneron’s Dupixent sBLA for the targeted treatment of bullous pemphigoid: Paris Wednesday, February 19, 2025, 12:00 Hrs [IST] The U ...
Stamford-based SpringWorks Therapeutics, a commercial-stage biotech company developing treatments for rare diseases and ...
MMJ's innovative soft gelatin THC-CBD capsule, known as MMJ-002, is undergoing the rigorous FDA approval process to ...
The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology.
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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