Business Wire13h
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) ...
FiercePharma14h
FDA approves Ono's rare tumor drug from $2.4B Deciphera buyout
A new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. | The new FDA approval gives ...
Medscape15h
FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumors
The US Food and Drug Administration has approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC) to treat adult ...
Healio20h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
SMA22h
FDA approves new tablet version of oral SMA treatment Evrysdi
The U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Evrysdi (risdiplam), an approved oral ...
Cure Today23h
Linvoseltamab BLA Resubmission Accepted by FDA for Review
The FDA accepted Regeneron’s BLA resubmission for linvoseltamab in relapsed or refractory multiple myeloma, with a decision ...
BioSpace23h
Roche’s Evrysdi Becomes First Pill Cleared for Spinal Muscular Atrophy
The FDA on Wednesday approved the industry’s first-ever tablet treatment for spinal muscular atrophy— Roche ’s SMN2 splicing ...
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Ryoncil ® was approved in December 2024 by the United States Food and Drug Administration (FDA) for steroid-refractory acute ...
Devonian Reports Positive Results in MASH Liver Study
Devonian Health Group Inc. ("Devonian" or the "Company") (TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on ...
Neurology Advisor1d
FDA Approves Symbravo for Acute Treatment of Migraine in Adults
The US Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
Contract Pharma1d
FDA Greenlights Roche’s Evrysdi Tablet
New 5mg tablet offers the same established efficacy and safety as the Evrysdi oral solution for individuals living with spinal muscular atrophy.
STAT2d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...