In a unanimous vote of 15-0, members of two FDA advisory committees agreed that the benefits of over-the-counter (OTC) intranasal naloxone far exceed any risks the long-approved drug might carry.…
In response to President Biden’s call for drug price-lowering demonstration projects, HHS has proposed three pilot programs designed to make therapeutics more affordable for Medicare and Medicaid beneficiaries. Source: Drug…
By the end of March, the Center for Drug Evaluation and Research (CDER)’s Office of Strategic Programs (OSP) will have met its first Prescription Drug User Fee Act (PDUFA) VII…
The concept of a multi-national concurrent review process for cell and gene therapies based on the current international partnership Project Orbis is just that — a concept with no immediate…
Ten percent of new drug approvals in the U.S. from 2018 to 2021 were based on pivotal studies that failed to meet at least one primary endpoint, according to a…
The FDA has issued a complete response letter (CRL) to Biocon and Viatris over their biologics license application (BLA) for bevacizumab, a proposed biosimilar of Roche’s blockbuster cancer drug Avastin.…
Newly released federal guidance details how the federal government will punish drug companies that hike prices faster than the rate of inflation for some prescription Medicare medicines — a move…
Two bipartisan bills reintroduced in the new Congress by Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) that seek to curtail prescription drugs costs have successfully passed the Senate Judiciary…
Indian generics company Sun Pharmaceuticals is facing yet another quality control issue as it recalls several lots of its blood pressure medication diltiazem hydrochloride in the U.S., after samples failed FDA…
An October FDA inspection of Hattiesburg, Miss.-based Pharmacy Plus (also known as Vital Care Compounder) found multiple issues with product sterilization, including problems in the ISO 5 classified aseptic processing…