Tenosynovial Giant Cell Tumors
Mar 03, 2025
Ono’s ROMVIMZA Triumph Sparks Battle with Daiichi Sankyo’s TURALIO in TGCT Space
Ono Pharmaceuticals received FDA approval on 14 February 2025 for vimseltinib, a treatment for tenosynovial giant cell tumor (TGCT), which will be sold under the brand name ROMVIMZA. This approval positions Ono in direct competition with fellow Japanese pharmaceutical company Daiichi Sankyo in the TGCT market. ...
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Feb 18, 2025
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis Galderma has announced that the European Commission has approved NEMLUVIO in the European Union (EU) to treat both moderate-to-severe atopic dermatitis and prurigo nodularis. The approval allows Nemluvio to be used subcutaneously for pat...
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Apr 23, 2024
Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation
Ipsen Partners with Skyhawk Therapeutics for RNA-Focused Research in Rare Neurological Disorders Ipsen and Skyhawk Therapeutics have entered into an exclusive global partnership to explore and create new small molecules that can influence RNA for rare neurological conditions. Under this agreement, Ipsen has the ...
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Dec 05, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...
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