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TXT Companies Say Pfizer Covid Booster Effective in Young Kids [2670 Words] [ Price : $8.95]
Pfizer says a Covid vaccine booster shot was effective in kids 6 months to under age 5.
05/23/2022
 
 
TXT Companies Push New Formulations for Blockbusters [2684 Words] [ Price : $8.95]
Researchers say drug companies are more likely to seek new formulations for blockbuster products and those given accelerated approval.
05/23/2022
 
 
TXT EMA Recommends Suspending Generics Tested by Synchron [2651 Words] [ Price : $8.95]
A European Medicines Agency committee says authorization of several generic medicines should be suspended because of questions about data submitted for their applications by India’s Synchron Research Services.
05/23/2022
 
 
TXT FDA Denies Tyvaso DPI Petition [2690 Words] [ Price : $8.95]
FDA denies a petition asking for restrictive agency actions on an NDA for Tyvaso.
05/23/2022
 
 
TXT CorneaGen Recalls 1 Lot of Scleral Patch Grafts [2659 Words] [ Price : $8.95]
FDA provides information on a CorneaGen recall of one lot of scleral patch grafts.
05/23/2022
 
 
TXT NeuroMetrix De Novo Authorization for Fibromyalgia [154 Words] [ Price : $8.95]
FDA grants NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity.
05/23/2022
 
 
TXT Warning on Genetic Prenatal Screening Tests [222 Words] [ Price : $8.95]
FDA issues a warning about the risks of false results with genetic non-invasive prenatal screening tests.
05/23/2022
 
 
TXT Bill Would Whittle Down Biologic Exclusivity [259 Words] [ Price : $8.95]
Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) reintroduce the bipartisan Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act to make biologics more affordable by reducing their exclusivity period from 12 years to five years.
05/20/2022
 
 
TXT Partial Clinical Hold on Leukemia Therapy [255 Words] [ Price : $8.95]
FDA issues a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia and myelodysplastic syndrome after a patient dies.
05/20/2022
 
 
TXT FDA Withdraws 21 No-longer-marketed ANDAs [56 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the products were no longer marketed.
05/20/2022
 
 
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