FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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.
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Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections.
The U.S. Food and Drug Administration (FDA) has granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.
Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration.
The U.S. Food and Drug Administration (FDA) granted San Diego-based Evofem Biosciences Fast Track designation for Amphora vaginal gel to prevent urogenital chlamydia infection in women.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Despite the recent dismal news regarding Alzheimer’s drug development, the U.S. Food and Drug Administration (FDA) recently proposed new guidelines for developing drugs for the disease.
Janssen got a little love from the FDA on Wednesday.
Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug.
The FDA approved Vertex’s Symdeko for cystic fibrosis in patients ages 12 and older with two copies of the F508del mutation.