Biologics

Breakthrough on Pfizer RSV Vaccine

FDA has granted Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use in preventing RSV-associated lower respiratory tract illness in infants from birth up to six months of age through active immunization of pregnant women. The designation is based on data from the company’s Phase 2b proof-of-concept study that is evaluating RSVpreF’s safety and immunogenicity in healthy pregnant women ages 18 through 49 years old and who were vaccinated between 28- and 36-weeks gestation, Pfizer says.

RSV is a contagious virus and a common cause of respiratory illness. It affects the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, the immunocompromised, and older adults.

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