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To save lives, the FDA must change how it evaluates rare disease treatments

For some conditions, few approved treatments exist. Without accelerated approval, the FDA is failing patients

United statesMatthew ellinwoodDrug administrationMark dantRare diseasesClinical trialsRomising treatmentsFood and drug administrationAccelerated approval pathwaySanfilippo syndromeLzheimer 39s diseaseApproved treatmentsAtional mps societyChildren and familiesEurodegenerative disease

How Soon Might Anavex s Alzheimer s Drug Be Approved? The Good/Bad News (NASDAQ:AVXL)

How Soon Might Anavex s Alzheimer s Drug Be Approved? The Good/Bad News (NASDAQ:AVXL)
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United statesChristopher misslingSoumit royAnavex life sciencesEuropean agencyAlzheimer phaseAccelerated approvalAccelerated approval pathwayDisease dementia phaseDisease dementia

FDA approves world s first vaccine for emerging global health threat : Prevention of a potentially debilitating disease

Valneva said it hopes to commercialize the vaccine in the U.S. early next year.

United statesPeter marksAdvisory committee on immunization practicesEuropean centre for disease preventionDrug administrationAccelerated approvalEast africanEuropean centreDisease preventionSoutheast asiaAdvisory committeeImmunization practicesBiologics evaluationFood and drug administrationChikungunya virusBiotech company

FDA eyes efficacy of $900K cancer drug

FDA panel urges Acrotech Biopharma to accelerate research into two blood cancer drugs approved via the FDA s accelerated approval pathway.

Acrotech biopharmaOncologic drugs advisory committeeDrugs advisory committeeAccelerated approval pathwayOncologic drugs advisory committeeAcrotech biopharmaLife saving drugsCovid 19

Schrader registers to lobby

The Oregon Democrat lost his bid for reelection last year and is now a principal at Williams and Jensen, which represents a number of pharmaceutical clients.

Capitol hillDistrict of columbiaUnited statesNew yorkTed cruzOzzie palomoLiz bowmanPatrick satalinChuck edwardsAshley davisMike lawlerGrayrobinson paJennifer larkin lukawskiPhillips obrienNikki haleyHannegan landau poersch rosenbaum