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Boehringer Ingelheim’s inhalation spray Striverdi Respimat has received FDA clearance for patients with chronic obstructive pulmonary disease, including those with airflow obstruction due to chronic bronchitis or emphysema. Read More
Manufacturers of new drugs, biologics and biosimilars will pay slightly more in user fees this fall for their applications, facilities and products. Read More
Difficulties finding the right patients for clinical trials and high active pharmaceutical ingredient costs are among the most pressing challenges in bringing new antibiotics for resistant infections to market. Read More
European regulators have approved Roche’s Gazyvaro in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL) patients who are unable to tolerate more intensive therapies. Read More
The FDA is continuing its push to help drugmakers better understand how they can use the agency’s expedited approval programs, releasing new details on how agency staff will review certain drugs in the breakthrough therapy pathway. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
Sandoz has become the first drugmaker to announce FDA acceptance of a biosimilar application with its cancer treatment filgrastim, a milestone that indicates the highly anticipated class of products may soon come to market more than four years after Congress approved a regulatory pathway. Read More