Tag: Food & Drug Administration
Top FDA Officials Say Two Full Doses of COVID-19 Vaccines a Must
Agency says it is understandable that people may want to stretch the vaccine supply, but it is not safe to do so
FDA Authorizes Marketing of EndoRotor System
Device provides minimally invasive way to resect and remove necrotic tissue in patients with walled-off pancreatic necrosis
FDA Approves Implant System for Transfemoral Amputations
The OPRA Implant System is surgically anchored and integrated into a patient's remaining thigh bone
Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations
Current approval of the once-daily tablet indicated for patients who have undergone complete tumor removal
FDA Issues EUA for Moderna COVID-19 Vaccine
On Sunday, ACIP voted to recommend frontline workers and those ages 75 years and older be included in next phase of vaccine distribution
FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer
Phase 3 trial data show 96.7 percent of patients who received Orgovyx achieved and maintained castrate levels of testosterone
Advisory Committee Votes to Recommend EUA for Moderna Vaccine
Could become the second COVID-19 vaccine in a week to receive emergency use authorization
FDA Authorizes Marketing of ACL Implant
The BEAR Implant offers alternative to ACL reconstruction with allograft, autograft, or suture-only repair
Pfizer-BioNTech Vaccine Receives Emergency Use Authorization
CDC director says vaccine distribution could begin as early as today
FDA Advisory Committee OKs Pfizer-BioNTech COVID-19 Vaccine
Committee recommends emergency use authorization of the vaccine; vaccine to be distributed within 24 hours of EUA
