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Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
It’s back to bench testing for a specialty drug company after the FDA rejected its new drug application for a combination drug and device pain treatment product. Read More
Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
The FDA approved Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, reversing its rejection this spring based on quality concerns at one of BI’s plants where the drug is made. Read More
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