FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
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.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
With the latest approval, Xtandi, an androgen receptor inhibitor, is now the only oral treatment approved by the FDA for three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
Vascepa capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid.