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Welcome to FDAweb Pay Per View Search our 70,821 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Next >>   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     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     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     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     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     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and J&J Covid vaccines. 10/21/2021     Real-World Data Standards Guidance [2688 Words] [ Price : $8.95] FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data. 10/21/2021     FDA Expanding Covid Work with Aetion [2722 Words] [ Price : $8.95] FDA expands its Covid-19 regulatory science work with Aetion. 10/21/2021     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     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     << Prev  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29  Next >>

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