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Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw materials used to manufacture them. Read More
The Federal Trade Commission (FTC) has filed a lawsuit against Endo Pharmaceuticals and Impax Laboratories alleging that a 2017 agreement between the companies violated the antitrust laws by eliminating competition in the market for an extended release opioid, oxymorphone ER. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
The World Health Organization (WHO) is recommending that pregnant women should not use Moderna’s vaccine, except for those deemed to be at high risk of infection. Read More
Johnson & Johnson (J&J) said it plans to release late-stage trial data for its COVID-19 vaccine candidate next week — a single-dose shot that could help the Biden administration exceed its goal of 100 million vaccinations in 100 days. Read More
The EU’s dispute with AstraZeneca (AZ) over the supply of the company’s vaccine intensified yesterday as European Commission (EC) officials met with the company and called on it to release the full terms of its European supply contract. Read More
A new study has found that Eli Lilly and Regeneron may need to adjust their monoclonal antibody treatments to effectively fight fast-spreading COVID-19 variants, especially the South African mutation, which along with a UK variant has raised concerns among scientists that SARS-CoV-2 may mutate to resist vaccines and treatments. Read More
Over-the-counter drugmaker US Pharmaceuticals of Belleville, N.J. drew a Form 483 from the FDA with four observations following an Oct. 6-16, 2020 inspection. Read More
Merck said Tuesday its blockbuster cancer drug Keytruda (pembrolizumab) has received European Commission approval as a standalone therapy for two types of colorectal cancer. Read More