FDA
Sanofi has announced that the U.S. FDA approved its new treatment for children one year of age or older diagnosed with late-onset Pompe disease.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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The first full business week of the new year began with plenty of clinical trial news. Here’s a look.
The State of California is considering a measure to sell its own brand of generic drugs in an effort to get in on those cost-savings. California’s Gov. Gavin Newsom is expected to reveal the scheme today in his new state budget.
Late Thursday, the U.S. Food and Drug Administration approved a new therapy to treat a rare mutation in patients with gastrointestinal stromal tumors.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
The company said Fiasp is the “first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.”
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The FDA issued a Complete Response Letter for its combination treatment of cabotegravir and rilpivirine.
Looking back over the past year and even decade, STAT News takes a look back at the best drugs approved over the past 10 years in its weekly Readout podcast.