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Jaypirca Combination Cuts Progression Risk by 45% in CLL Trial: Lilly

[ Price : $8.95]

Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and ritux...

Plausible Mechanism Faces Challenges: Commentary

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Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a comme...

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...

Petition urges FDA to Ban Gadolinium MRI Contrast Agents

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A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.

FDA Authorizes Colorado Prescription Drug Importation Program

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FDA authorizes Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug ...

FDA, MHRA Launch Liaison Program for Regulatory Cooperation

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FDA and the UK's Medicines and Healthcare products Regulatory Agency announce a new liaison program designed to strengthen collabo...

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...

Draft Guidance Clarifies Orange Book Patent Submission Forms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FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Boo...