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Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
A Phase III trial of the flutiform inhaler did not meet its primary endpoint of demonstrating statistically significant superiority in the reduction of annualized rates of moderate and severe exacerbations of chronic obstructive pulmonary disease, when compared to mono-component long-acting β2-agonist treatment alone. Read More
Vitalife received an FDA warning letter after an inspection revealed violations of the agency’s cGMP rules. The agency also challenged claims made on Vitalife’s website related to three of its products. Read More
The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. Read More
The number of cardiovascular drugs entering the clinical development pipeline has been declining since 1990, according to a study evaluating public data from over 4,000 trials. The decline was seen across Phase I, II, and III clinical trials. Read More