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Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate - Hagens Berman
12 Sep 2025 15:45 GMT
… effectively rejected the drug’s approval for advanced melanoma. The news triggered … Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate The lawsuit claims … the IGNYTE trial.
The FDA was likely to find the trial's …
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SMALL CAP MOVERS: Lupus drug patent lights up the market as pharma group soars 527%
12 Sep 2025 13:01 GMT
… .
Currently being developed to treat Lupus, P140 potentially has … of conventional immunosuppressants, the drug has been hailed as … could succeed where other treatments have fallen short. The … encouraging results from its melanoma vaccine trial in July, and …
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‘So Much More Hope’: How Immunotherapy Changed Melanoma Care
12 Sep 2025 08:02 GMT
… treatment for advanced melanoma involved chemotherapy and early immunotherapy drugs … the FDA approved the anti-CTLA-4 drug ipilimumab, … pivotal CheckMate 067 trial, which compared first … relationships with numerous pharmaceutical companies, including Bristol …
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Indication Expansion Accelerates: First Patient Dosed in Melanoma Phase 1b/II Trial of Opamtistomig
12 Sep 2025 05:16 GMT
… the first-line treatment of advanced melanoma.
Opamtistomig, a uniquely … rates in hard-to-treat cancers.
In two … pivotal single-arm registration trial evaluating Opamtistomig monotherapy … .S. Food and Drug Administration (FDA) for neuroendocrine carcinoma …
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Darovasertib Delivers Promising Antitumor Activity in Uveal Melanoma
11 Sep 2025 22:44 GMT
… randomized phase 3 OptimUM-10 trial (NCT07015190) is exploring neoadjuvant darovasertib … breakthrough therapy4 and orphan drug designations5 from the FDA.
REFERENCES:
1. … drug designation for darovasertib, a PKC inhibitor, for the treatment of uveal melanoma …
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Cutaneous Squamous Cell Carcinoma Treatment Market to Hit USD 27.54 Billion by 2034
11 Sep 2025 14:30 GMT
… of new medications, a strong pipeline of treatments, and the … attention, with key drugs like cemiplimab demonstrating high … Hoffmann-La Roche Ltd., Regeneron Pharmaceuticals Inc., Merck & … U.S. Food and Drug Administration (FDA) approved cosibelimab-ipdl …
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WHO adds blockbuster weight loss drugs to essential medicine list: Why this can broad-base therapies for obesity, cancer
11 Sep 2025 09:40 GMT
… receptor GLP-1 and GIP drug tirzepatide, all of which … safety.”
Why were weight loss drugs included?
Last year, senior … have so far failed to treat obesity or turn the tide … alternative therapy for the treatment of malignant melanoma — a dangerous form …
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Big Beautiful Bill Reduces Drugs Eligible for Price Negotiations
11 Sep 2025 02:55 GMT
… 2028.
An orphan drug is a medication to treat a condition with … , pharmaceutical companies did not have the incentive to develop drugs for … Drug Act allowed for priority review of applications at the FDA … for patients with advanced melanoma who have a BRAF …
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Rockefeller Antibody Eradicates Metastatic Tumors in Phase 1 Trial
11 Sep 2025 00:19 GMT
… Phase 1 clinical trial of an enhanced immunotherapy drug. The therapy … of drugs long plagued by limitations.
The drug in … patient’s metastatic melanoma vanished entirely after treatment, while another’s … to other hard-to-treat malignancies. The therapy works …
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Nemvaleukin Shows Durable Antitumor Activity in Melanoma, RCC
10 Sep 2025 20:30 GMT
… results from the ARTISTRY-1 trial (NCT02799095).1
This analysis focuses … , pharmacokinetics, and pharmacodynamics.
Investigators reported an overall response rate (ORR) in melanoma and … both melanoma and RCC cohorts received a median of 6 treatment cycles …