We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Following a month-long inspection in August, the FDA reprimanded Catalent for numerous quality lapses observed at its Bloomington, Ind., plant — where the drugmaker has performed manufacturing activities for both Moderna’s and Johnson & Johnson’s COVID-19 vaccines. Read More
In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory Committee. Read More
Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for documentation to present to reluctant brand-name owners. Read More
“Clinical data to date indicate this investigational approach provides benefits in multiple tissues evaluated, including the eyes, skin, gastrointestinal mucosa and the neurocognitive system,” the company said. Read More
Aponvie will offer an option for the approximately 36 million patients undergoing surgical procedures in the country each year with high to moderate risk for PONV, Heron said. Read More
In a win for Amyndas Pharmaceuticals, the U.S. District Court in Massachusetts has overturned a lower court ruling that had dismissed the company’s complaint of misappropriation of trade secret agreements by Zealand US, allowing Amyndas to continue its legal battle. Read More