Drug for Rare Form of ALS Earns FDA Nod
The FDA granted accelerated approval to tofersen (Qalsody) for amyotrophic lateral sclerosis (ALS) patients with mutations in the SOD1 gene, the agency announced on Tuesday. The drug was cleared under the accelerated approval pathway, a program that uses a surrogate endpoint to approve drugs for serious conditions with an unmet medical need. For tofersen, the […]
Federal Judge Halts FDA’s Abortion Pill Approval
A federal judge in Texas on Friday suspended the FDA’s 2000 approval of mifepristone (Mifeprex) — the most commonly used drug for medication abortion nationwide. Importantly, Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, also stayed the effective date of his order for 7 days to allow the federal […]
FDA Greenlights New First-Line Regimen in Bladder Cancer
The FDA gave accelerated approval to enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) as first-line treatment for certain patients with locally advanced or metastatic urothelial cancer, the agency announced on Monday. Specifically, the combination is indicated for those who are ineligible for cisplatin-containing chemotherapy, and the approval marks the first anti-PD-1/antibody-drug conjugate combination for this patient […]
OTC Narcan Approval Opens New Doors in Fight Against Opioid Crisis
This week’s FDA approval of the first-ever over-the-counter (OTC) naloxone product (Narcan) for the treatment of opioid overdoses was broadly praised, but medical and industry experts expressed caution about expanding access and its potential to address the overdose crisis. “We have nearly 200 Americans dying every day as a result of opioid-involved overdose,” said Smita […]
FDA Panel Backs Full Approval of Paxlovid for COVID-19
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19. By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to […]
Abortion Pill Fight Heats Up; Cancer Screening Still in a Slump; 5 Good Sleep Habits
Note that some links may require subscriptions. A lawsuit challenging FDA approval of the abortion drug mifepristone (Mifeprex) has the potential to undermine the entire drug approval process in the U.S. (STAT) Could you repeat that? Health authorities said China’s COVID epidemic is “basically over” but “not yet ended.” (Reuters) Too many people who are […]
FDA OKs Sparsentan for IgA Nephropathy-Related Proteinuria
The FDA granted accelerated approval to sparsentan (Filspari) for proteinuria in IgA nephropathy, Travere Therapeutics announced, marking the first non-immunosuppressive therapy for this rare condition. Also known as Berger’s disease, proteinuria in IgA nephropathy is the leading cause of kidney failure due to glomerular disease, and sparsentan is specifically indicated to reduce proteinuria in adults […]
Michael Wang on the Reversible BTK Inhibitor for Previously Treated MCL
The FDA recently granted accelerated approval to pirtobrutinib (Jaypirca), a reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor. In this exclusive MedPage Today video, Michael Wang, MD, of the University of Texas MD […]
Alzheimer’s Drug Lecanemab Wins FDA Approval
Lecanemab (Leqembi) was approved under the accelerated approval pathway to treat Alzheimer’s disease, the FDA announced on Friday. The anti-amyloid should be started only in patients with mild cognitive impairment or who are at the mild dementia stage of Alzheimer’s disease, the population studied in clinical trials, the agency noted, and the drug label indicates […]
FDA Moves to Pull Controversial Preterm Birth Drug From the Market
The FDA is calling for withdrawal of the approval for the injectable agent 17α-hydroxyprogesterone caproate (17-OHPC; Makena) for pregnant women with a history of at least one spontaneous preterm birth, stating that the drug is ineffective in reducing preterm births, as well as other poor neonatal outcomes, according to briefing documents released ahead of a […]