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TXT Bill Would Prevent Conflicting FDA Consultant Contracts [404 Words] [ Price : $8.95]
A Senate bill seeks to bar conflicts of interest in consulting contracts, such as those FDA signed with McKinsey & Co. on regulatory actions involving opioids while the company was also advising opioid maker Purdue Pharma.
03/28/2022
 
 
TXT Staar Surgical Implantable Vision Correction Lens OK’d [183 Words] [ Price : $8.95]
FDA approves a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia and myopia with astigmatism.
03/28/2022
 
 
TXT Drug User Fee Notice Correction [75 Words] [ Price : $8.95]
Federal Register notice: FDA corrects an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.”
03/25/2022
 
 
TXT Review Extension Bristol-Myers sBLA for Reblozyl [134 Words] [ Price : $8.95]
Reblozyl is currently approved to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes in patients who did not respond adequately to an erythropoietin-stimulating agent and requiring red blood cell transfusions.
03/25/2022
 
 
TXT BMS Resolves Abraxane Drug Shortage [313 Words] [ Price : $8.95]
Bristol-Myers Squibb says it has resolved manufacturing constraints that led to “global supply challenges” for Abraxane for injectable suspension.
03/25/2022
 
 
TXT AviClear Acne Laser Treatment Cleared [81 Words] [ Price : $8.95]
FDA clears a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne.
03/25/2022
 
 
TXT FDA PI3K Concerns Hits MEI Pharma’s Zandelisib [538 Words] [ Price : $8.95]
Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated approved of a BLA for zandelisib based on data from their single-arm Phase 2 TIDAL study.
03/25/2022
 
 
TXT House Panel Grills FDA on Medtronic Heart Pump [379 Words] [ Price : $8.95]
The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronic’s troubled HeartWare Ventricular Assist Device (HVAD) System — a recalled heart pump device associated with more than 20,000 patient injuries and 3,000 deaths.
03/25/2022
 
 
TXT Senate Passes Marijuana/CBD Research Bill [348 Words] [ Price : $8.95]
The Senate passes the “Cannabidiol and Marijuana Research Expansion Act” that is intended to ensure that research on cannabidiol and other potentially beneficial marijuana-derived substances is based on sound science while reducing the regulatory barriers associated with conducting such research.
03/25/2022
 
 
TXT GSK/Vir Sotrovimab EUA Excludes New Variant Use [140 Words] [ Price : $8.95]
FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikely to be effective in Covid-19 patients infected by the Omicron BA.2 variant.
03/25/2022
 
 
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