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FDA Warns Telehealth Firms on Compounded GLP-1 Marketing

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FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading ...

Neumora Halts Development of Navacaprant After Phase 3 Miss

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Neumora Therapeutics discontinues development of its lead depression candidate navacaprant after two Phase 3 studies failed to mee...

Draft Guidance Clarifies Orange Book Patent Submission Forms

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FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Boo...

Welireg-Keytruda Combo OKd as Adjuvant Kidney Cancer Therapy

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FDA approves Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patien...

Amgen Outlines Basis for Hearing in Tavneos Withdrawal Effort

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A just-posted notice from Amgen outlines the basis for the company's defense of why its ANCA-associated vasculitis drug Tavneos sh...

Jazz Trial Misses Survival Endpoint for Zepzelca in Lung Cancer

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Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed t...

AstraZeneca's Truqap for Prostate Cancer Approved

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FDA approves AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN...

17 Senate Democrats Hit HHS on FDA, Other Changes

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Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing ...

Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

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Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Bristol Myers Squibbs Sotyktu in a ...

CGMP Violations Seen in Port Jervis Records Review

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FDA cautions Port Jervis Laboratories in Port Jervis, NY, about CGMP violations in its manufacturing of over-the-counter drugs.