Approval was supported by the phase 3 LANDI-PED study, which demonstrated significant heart rate reduction and conversion to normal sinus rhythm in pediatric patients.
Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in ...
Apotex, in collaboration with Orbicular Pharmaceutical Technologies and Gland Pharma, have received permission from the Food ...
Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international guidance, as well as other ...
Novo Nordisk (NYSE:NVO) is advancing the launch of an oral version of Ozempic, expanding its GLP-1 diabetes franchise beyond injectable formats. The company is also seeking regulatory approvals to ...
Rocket Pharmaceuticals has offloaded its lucrative FDA rare pediatric disease priority review voucher (PRV), striking a $180 ...
Laguna Biotherapeutics, Inc. (Laguna), a clinical-stage biotechnology company focused on novel live bacterial therapeutics, ...
BrioHealth has received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device in ...
The US Food and Drug Administration (FDA) on Monday released revised draft guidance on rare pediatric disease priority review vouchers (PRVs), which are awarded to companies developing certain rare ...
Iopofosine-131 received rare pediatric drug designation for treating relapsed or refractory pediatric high-grade glioma, highlighting its potential in addressing aggressive pediatric brain cancers.
On February 3, 2026, the President signed the Consolidated Appropriations Act of 2026 (the CAA) into law and ended a partial government shutdown. 1 The Act included two changes that directly affect ...
Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results