Drug Safety

FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.

Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.

A revised pharmacovigilance guideline will come into effect in New Zealand on 1 July, although sponsors may start using it now.

The agency's and the pharma industry’s worst fears – that a potential ruling in the mifepristone case might usurp the FDA’s scientific authority and throw the stability of the US drug approval process into question – seem unlikely to materialize as the majority of the Supreme Court justices signal the Alliance for Hippocratic Medicine lacks standing to sue.

The EU’s pharmacovigilance committee says that a review of the available evidence showed that in several cases, blood levels of immunosuppressants increased rapidly to toxic levels in patients who were taking the Pfizer drug.

New poll from advocates pushing for courts and the states to stay out of FDA’s scientific decisions indicates majority of US voters support FDA drug safety determinations across party lines, though Republican support is more tentative.

Oncologic Drugs Advisory Committee also favors earlier use of Bristol-Myers Squibb’s Abecma in multiple myeloma, although some members raise concerns about lack of plateau in progression-free survival benefit and equivocable overall survival data.

Deaths that occurred before a patient randomized to one of the CAR-T products received that treatment don’t necessarily negate the FDA’s concerns, because risks associated with administration of treatment are “integral to the benefit-risk assessment,” the agency said.

Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment.

Close watchers of Lilly’s Alzheimer’s drug believe FDA’s last-minute advisory committee request is to deal with how to translate a complicated trial design into label recommendations, not because the agency is thinking of rejecting the drug, which had been seen as a shoo-in for approval.

Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.

US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.

Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.