As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued a final guidance on the use of five International Organization…
The White House has laid out “bold goals” to use biomanufacturing breakthroughs to produce at least 25 percent of all active pharmaceutical ingredients (API) for small-molecule drugs in the U.S.…
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections, new drug products won’t get approved…
The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC…
Esperion is suing Daiichi Sankyo over a failure to pay a $300 million milestone payment for the cardiovascular drug Nexletol (bempedoic acid), a treatment for heterozygous familial hypercholesterolemia or established…
The FDA announced yesterday that its generic drug program has resumed in-person, face-to-face meetings with industry, in a phased-in approach alongside videoconference meetings. Source: Drug Industry Daily
The Senate Commerce, Science and Transportation Committee has passed a bill that would force pharmacy benefit managers (PBM) to be upfront about their often murky pricing practices and compel them…
The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that…
GOTHENBURG, SWEDEN — The FDA correctly approved Biogen’s Aduhelm (aducanumab) in 2021 because the drug met the criteria for disease modification the agency had laid down for Alzheimer’s disease (AD)…
A California judge has ruled that a lawsuit by one individual against GlaxoSmithKline (GSK) for its heartburn drug, Zantac (ranitidine), may go ahead — potentially setting the stage for other…