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TXT Study Shows Viagra Promise in Alzheimer’s [2779 Words] [ Price : $8.95]
A Cleveland Clinic study says sildenafil may have a treatment benefit for Alzheimer’s patients.
12/08/2021
 
 
TXT Dentsply Exits Dental Amalgam Market [737 Words] [ Price : $8.95]
Anti-dental amalgam activists savor a victory as Dentsply Sirona – the world’s largest manufacturer of dental products – exits the amalgam market.
12/08/2021
 
 
TXT AAM Comments on Controlled Correspondence [2737 Words] [ Price : $8.95]
The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workload.
12/08/2021
 
 
TXT Biosimilars Forum, PhRMA Support BsUFA 3 [2901 Words] [ Price : $8.95]
The Biosimilars Forum and PhRMA say they support the third biosimilar user fee agreement negotiated with FDA.
12/08/2021
 
 
TXT Lessons Learned from Gene Therapies: CBER Official [425 Words] [ Price : $8.95]
CBER Office of Tissues and Advanced Therapies director Wilson Bryan addresses the lessons learned from FDA’s limited experience in approving seven gene therapies to date.
12/08/2021
 
 
TXT EUA Approved for AstraZeneca’s Evusheld [2789 Words] [ Price : $8.95]
FDA issues an emergency use authorization for AstraZeneca’s Evusheld monoclonal antibody Covid pre-exposure prevention for some adults and pediatric patients.
12/08/2021
 
 
TXT Teligent Recalls 2 Topical Lidocaine Lots [145 Words] [ Price : $8.95]
Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal testing determining the product is super potent.
12/08/2021
 
 
TXT Gilead Recalls 2 Veklury Lots [88 Words] [ Price : $8.95]
Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates.
12/07/2021
 
 
TXT FDA’s Broadening Approval Authority Explained [2823 Words] [ Price : $8.95]
Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug product regulation by considering the population health implications.
12/07/2021
 
 
TXT 510(k) Required for Powered Patient Transports: FDA [88 Words] [ Price : $8.95]
Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the generic device type: powered patient transport (product code ILK).
12/07/2021
 
 
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