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An FDA advisory committee voted Wednesday in favor of Chiesi’s Bronchitol (inhaled mannitol) for improving lung function in cystic fibrosis patients aged 18 and older. Read More
PhRMA on Wednesday pushed back against a final rule that will require drugmakers to offer a treatment’s list price as part of television ads, hinting that a First Amendment lawsuit might be on its way. Read More
Sharpless, who had been serving as director of the National Cancer Institute, acknowledged that it’s a tough act to follow former Commissioner Scott Gottlieb. Read More
Pennsylvania compounder Summit Health Pharmacy has petitioned the FDA to include oxitriptan on the agency’s 503A bulk substances list—and says the agency should also allow it for compounding in the meantime. Read More
Pfizer is calling on the FDA to retroactively assign four-letter suffixes to biologics that act as reference products for innovative biosimilars. Read More
PhRMA will back “responsible” drug patent reforms, but lawmakers would do well to remember how essential patent protections are to getting life-saving medicines to patients, one of the group’s executives told a Senate panel Tuesday. Read More