The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical ...
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) has approved ROMVIMZA™ (vimseltinib), a kinase ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
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