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Guidance on Drugs for Preventing Migraines

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Federal Register notice: FDA makes available a draft guidance entitled Migraine: Developing Drugs for Preventive Treatment.

FDA Withdraws 8 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they informed the agency that the pr...

FDA OKs Pfizer Abrysvo RSV Vaccine

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FDA approves Pfizers Abrysvo vaccine to prevent respiratory syncytial virus in older adults.

FDAs Expands Use of Lynparza in Prostate Cancer

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FDA approves AstraZeneca and Mercks Lynparza (olaparib) in combination with Janssens Zytiga (abiraterone) and prednisone or predni...

Migraine Drug Development Guidance

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FDA publishes a draft guidance on the clinical development of drugs to prevent migraine.

AstraZeneca Ends Brazikumab Development

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AstraZeneca says it is ending its brazikumab development program that was being studied for Crohns disease and ulcerative colitis....

FDA Warning on Unapproved Molluscum Treatments

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FDA issues a warning against using unapproved products that claim to treat molluscum.

Balance AI Optimism and Pessimism: Califf

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FDA commissioner Robert Califf says he sees value in artificial intelligence and agrees that its important to also look at the ris...

Roche/Genentech Suggestions for nAMD Guidance

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Roche/Genentech make suggestions for clarification and improvement to an FDA draft guidance on developing treatments for neovascul...

Patient Access to At-Home Technologies

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CDRH asks for public comment on eight questions about using medical technologies in a home setting.