Biologics

Panel to Discuss Pfizer Booster Vaccine 9/17

FDA has announced a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTech’s supplemental BLA seeking approval for a booster dose of Comirnaty (Covid-19 vaccine, mRNA) in individuals 16 years of age and older. “The process for authorizing or approving the use of a booster dose of a Covid-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use,” CBER director Peter Marks said in a release. “Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.” The timing of the panel meeting aligns with recent White House guidance suggesting that a booster vaccine could become available around 9/20.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome