FDA Approves Moderna, J&J Booster Shots, Backs Mix ‘n’ Match Vaccines
Agency’s decision is one of the last steps toward a full rollout of booster shots to eligible Americans
FDA
FDA Expected to Allow Mix ‘n’ Match COVID-19 Vaccines
Agency will not recommend one vaccine over another but may say it is preferable to use same booster as the vaccine
Former FDA Chief Robert Califf a Contender to Head Agency Again
FDA has not had a permanent head for more than eight months, is being overseen by Acting Commissioner Janet Woodcock
Precedent Needed for FDA Approval Decisions When Evidence Lacking
In 7 of 22 cases, approval used new interpretations of original evidence and did not require new evidence
Some Cancer Drugs Without Proven Benefit Still Recommended
Six of 18 indications remain on label for cancer drugs that failed to improve primary end point in trials after receiving accelerated approval
Outcomes of BCG-Unresponsive NMIBC Characterized
In a small study, most BCG-unresponsive patients who were initially managed conservatively ultimately underwent cystectomy.
FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
Cinacalcet Does Not Up Risk for Severe Gastrointestinal Bleeding in Hemodialysis
Study is the largest to explore this potential safety issue to date.
Report Questions Benefit of FDA Accelerated Approval Pathway
112 of the 253 authorized drugs have not been confirmed as clinically effective; 24 of these have been on market more than 5 years
FDA OKs Third COVID-19 Vaccine Dose for Immunocompromised Patients
Here’s what clinicians and patients need to know.
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