FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3
Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease
The U.S. Food and Drug Administration cleared Abbott’s blood test to help aid in the diagnosis of heart attacks for men and women hours earlier than standard tests and marks significant progress for detecting heart attacks in women.
The vaccine is the only approved non-replicating smallpox vaccine in the U.S. and the only approved monkeypox vaccine anywhere in the world, the company said.
U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patientsbwith Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration late Friday, marking it as the first such treatment to be approved in pill form.
Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.
The U.S. Food and Drug Administration approved Keytruda in combination with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma.
Erleada is an androgen receptor inhibitor approved for non-metastatic castration-resistant prostate cancer.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.