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TXT Pfizer Seeking EUA for ‘Promising ’ Covid Antiviral [297 Words] [ Price : $8.95]
Promising new data on its investigational Covid-19 oral antiviral agent Paxlovid PF prompts Pfizer to plan its early submission to the ongoing rolling submission seeking FDA Emergency Use Authorization.
11/05/2021
 
 
TXT ReWalk Robotics ‘Breakthrough’ on Home Exo-suit [150 Words] [ Price : $8.95]
FDA grants ReWalk Robotics a breakthrough device designation for its ReBoot, an exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries.
11/05/2021
 
 
TXT Panel Votes Down Prader-Willi Syndrome Drug [171 Words] [ Price : $8.95]
An FDA advisory committee votes 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome did not show significant evidence of effectiveness.
11/05/2021
 
 
TXT FDA Approves Dyanavel XR ADHD Tablets [83 Words] [ Price : $8.95]
FDA approves a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorder in patients six years and older.
11/05/2021
 
 
TXT Pathogen Reduction in Blood Components Guide [72 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers.
11/04/2021
 
 
TXT Orphan Designation for Menarini Leukemia Drug [2616 Words] [ Price : $8.95]
FDA grants orphan drug designation to an investigational Menarini drug to treat relapsed/refractory acute myeloid leukemia.
11/04/2021
 
 
TXT Guide on Device Software Submissions [75 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Content of Premarket Submissions for Device Software Functions.
11/04/2021
 
 
TXT All Companies Stopping Isoxsuprine Distribution [2724 Words] [ Price : $8.95]
FDA says all manufacturers and labelers of isoxsuprine HCl products have agreed to cease distribution of them.
11/04/2021
 
 
TXT FDA Patient Cybersecurity Best Practices Video [2634 Words] [ Price : $8.95]
FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.
11/04/2021
 
 
TXT 3 Observations in Atlas Pharmaceuticals FDA-483 [2647 Words] [ Price : $8.95]
FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, AZ.
11/04/2021
 
 
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