News

dvm3609h
FDA approves first generic methimazole tablet for feline hyperthyroidism
This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...
Healio8h
FDA rejects RP1 for advanced melanoma, says IGNYTE not a ‘well-controlled’ trial
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...
Targeted Oncology10h
FDA Issues CRL for RP1 in Advanced Melanoma
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
MPR10h
FDA Denies Approval of Vusolimogene Oderparepvec for Advanced Melanoma
Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.
FDA Approves Prefilled Syringe Presentation for Shingles Vaccine
Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...
STAT11d
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
The American Journal of Managed Care10h
FDA Issues CRL for Vusolimogene Oderparepvec in Advanced Melanoma
The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.
Engadget5y
NASA will license its FDA-approved ventilator to ... - Engadget
A high-pressure ventilator developed by NASA engineers and designed to treat COVID-19 has received FDA approval via a fast-tracked emergency use authorization.