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TXT ViiV’s Cabenuva Approved for HIV-1 in Adolescents [221 Words] [ Price : $8.95]
FDA approves ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in certain virologically suppressed adolescents.
03/29/2022
 
 
TXT Biobeat 510(k) for Expanded Wearable Patient Monitor [135 Words] [ Price : $8.95]
FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate.
03/29/2022
 
 
TXT Stakeholders Comment on Digital Data Acquisition Draft [2912 Words] [ Price : $8.95]
Stakeholders give comments and suggestions to FDA on its draft guidance on using digital health technologies for remote data acquisition.
03/29/2022
 
 
TXT Comments on FDA Device Transition Guidance [2743 Words] [ Price : $8.95]
Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 public health emergency ends.
03/29/2022
 
 
TXT FDA Approves Higher Dose of Ozempic Diabetes Drug [2628 Words] [ Price : $8.95]
FDA approves a 2 mg dosage level of Novo Nordisk’s diabetes drug Ozempic.
03/29/2022
 
 
TXT FDA Questions ‘Modest’ Benefit in ALS Drug [497 Words] [ Price : $8.95]
An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data contained in Amylyx Pharmaceuticals’ NDA for its experimental amyotrophic lateral sclerosis therapy.
03/28/2022
 
 
TXT Device Rule Reduces Paper Copy Submissions [101 Words] [ Price : $8.95]
Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of certain documents that need to be submitted.
03/28/2022
 
 
TXT Animal Drug Regs Amended for Approvals [89 Words] [ Price : $8.95]
Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2021, 11/2021 and 12/2021.
03/28/2022
 
 
TXT Senator Scott Urges FDA to Fill Vacancies [482 Words] [ Price : $8.95]
Senator Rick Scott (R-FL) urges FDA to fill vacant management posts at CDER and CBER because FDA is too important an agency to operate under temporary leadership.
03/28/2022
 
 
TXT FDA Budget Request Seeks $2.1 Billion Spending Boost [1030 Words] [ Price : $8.95]
FDA outlines a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of president Biden’s just-released budget request, which includes $3.7 billion in budget authority – an almost 10% increase of $356 million from the current authorized spending level.
03/28/2022
 
 
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