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TXT CytoDyn Resubmits Rolling BLA for HIV Therapy [199 Words] [ Price : $8.95]
CytoDyn begins resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for highly treatment-experienced HIV patients.
11/16/2021
 
 
TXT MIDD Pilot Updated [2673 Words] [ Price : $8.95]
FDA says it is asking the Model-Informed Drug Development meeting requests and packages to include a credibility framework.
11/16/2021
 
 
TXT Scientists Ask How FDA Will Review New Alzheimer Drugs [2794 Words] [ Price : $8.95]
The journal Nature explores researchersí questions about how FDA will act on two new amyloid-β therapies for Alzheimerís disease, given its experience with Biogenís Aduhelm.
11/16/2021
 
 
TXT Improve FDA ClinicalTrials.gov Enforcement: Researchers [2822 Words] [ Price : $8.95]
Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.
11/16/2021
 
 
TXT De Novo Granted for Virtual Reality for Pain [333 Words] [ Price : $8.95]
FDA authorizes the de novo marketing of AppliedVRís EaseVRx, a prescription-use immersive virtual reality system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction.
11/16/2021
 
 
TXT Medtronic PillCam At-Home Endoscopy [176 Words] [ Price : $8.95]
FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.
11/16/2021
 
 
TXT Multiple Violations at Guyer Institute [3136 Words] [ Price : $8.95]
FDA warns Guyer Institute of Molecular Medicine about CGMP and other violations in its production of compounded drugs.
11/16/2021
 
 
TXT Pfizer Covid Pill Reduces Hospitalization/Death: Study [162 Words] [ Price : $8.95]
Pfizer says it will submit new data for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization and death.
11/16/2021
 
 
TXT Upton, DeGette Introduce Cures 2.0 [2931 Words] [ Price : $8.95]
Reps. Upton and DeGette introduce their bipartisan Cures 2.0 legislation to create an Advanced Research Projects Agency-Health to work on cures and treatments for several severe diseases.
11/16/2021
 
 
TXT PhRMA Strategies to Enhance Trial Diversity [2707 Words] [ Price : $8.95]
PhRMA and Deloitte release a report with strategies for increasing clinical trial diversity.
11/16/2021
 
 
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