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The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More
Drugmakers Hoffman-La Roche and Hyperion Therapeutics are taking part in Health Canada’s new orphan drugs pilot project to better understand how patient input may be gathered and incorporated into the drug submission review process. Read More
The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections. Read More
The European Commission approved Roche’s cancer drug Avastin in combination with chemotherapy to treat women with recurring ovarian cancer that is resistant to platinum-containing chemotherapy. Read More
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