• ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • Regulatory NewsRegulatory News

    FDA trims Aduhelm's indicated population

    Biogen’s newly approved Alzheimer’s disease drug Aduhelm (aducanumab-avwa) received a labeling update Thursday to clarify that the drug is meant for individuals with mild cognitive impairment or dementia due to Alzheimer’s disease.   Just last month, Aduhelm received accelerated approval from the US Food and Drug Administration (FDA), a controversial decision that ran counter to the strong opinions of the agency’s Peripheral and Central Nervous System advisory committe...