Drugs

Lantheus NDA for Pylarify New Formulation

FDA has accepted a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen (PSMA) imaging agent, submitted by its affiliate, Aphelion. The agency has set a user fee review action target date of 3/6/2026.

The new formulation builds on Lantheus’ current prostate cancer imaging agent, Pylarify (piflufolastat F 18) and its use for detecting recurrent prostate cancer in men with rising prostate-specific antigen (PSA) levels. According to Lantheus, the updated formulation is expected to maintain the same diagnostic efficacy while significantly increasing manufacturing efficiency — potentially boosting the number of doses per batch by about 50%.

Approved for PET imaging of PSMA-positive lesions in men with prostate cancer, Pylarify helps clinicians assess both suspected metastasis and disease recurrence, according to the company. It combines PSMA targeting with fluorine-18 radiolabeling for high diagnostic clarity and has been used in more than 500,000 scans across the U.S., it adds.

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