A recently published study of new drugs approved by the FDA from 1995 to 2014 showed that sales of most products (75 percent) exceeded the industry-wide costs of development within…
In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier…
The FDA has approved Guardant’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. Source: Drug Industry…
This week, the FDA published notice of user fee rates for fiscal year 2025. Source: Drug Industry Daily
This edition of Quick Notes includes EU approval of Pfizer’s hemophilia B gene therapy Durveqtix, a positive EMA opinion on an expanded label for Wegovy, two new EMA draft guidelines…
A Baxter Healthcare drug manufacturing plant in Marion, N.C., has been hit with another Form 483 after an FDA inspection early in the year revealed more deficiencies, including two that…
Immediately after the FDA rejected Novartis’s 2022 citizen petition for the agency to refrain from approving generic versions of its cardiac drug Entresto (sacubitril and valsartan), the company has filed…
Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new…
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of…
AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Source: Drug Industry Daily