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TXT Susvimo Eye Implant for Wet AMD Approved [310 Words] [ Price : $8.95]
FDA approves Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating certain people with wet, or neovascular, age-related macular degeneration.
10/22/2021
 
 
TXT FDA Withdraws Approval for 216 ANDAs [85 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports.
10/22/2021
 
 
TXT Biden Meets with Potential FDA Head Califf [436 Words] [ Price : $8.95]
President Biden meets with potential FDA commissioner nominee Robert Califf in what may be the last step before an official announcement.
10/22/2021
 
 
TXT Regulatory Review Determined for Orion’s Nubeqa [90 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide).
10/21/2021
 
 
TXT Comments Sought on Xenotransplantation Guideline [110 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”
10/21/2021
 
 
TXT FDA Denies Vaccine EUA Revocation Petition [2757 Words] [ Price : $8.95]
FDA denies an Informed Consent Action Network petition asking it to revoke the EUAs for the Moderna and J&J Covid vaccines.
10/21/2021
 
 
TXT Real-World Data Standards Guidance [2688 Words] [ Price : $8.95]
FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data.
10/21/2021
 
 
TXT FDA Expanding Covid Work with Aetion [2722 Words] [ Price : $8.95]
FDA expands its Covid-19 regulatory science work with Aetion.
10/21/2021
 
 
TXT FDA OKs Luminopia One for Lazy Eye [2712 Words] [ Price : $8.95]
FDA gives de novo premarket approval to Luminopia One to use a virtual reality headset to treat amblyopia, or lazy eye, in children ages 4-7.
10/21/2021
 
 
TXT Clinical Hold on AZ Blood Cancer Drug [2684 Words] [ Price : $8.95]
FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one patient.
10/21/2021
 
 
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