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.
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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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Genentech snagged a new regulatory approval for its hemophilia treatment, Hemlibra. On Thursday the U.S. Food and Drug Administration approved the medication for hemophilia A patients who do not have factor VIII inhibitors.
Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai’s antiepileptic drug (AED) Fycompa (perampanel)
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for migraine prevention.
The U.S. Food and Drug Administration approved Pfizer’s once-per-day oral medication Vizimpro, a first-line treatment for patients with a rare form of lung cancer, the company announced late Thursday.
The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.
Shares of Verastem closed out Monday trading on a positive note and continues to climb in the premarket following the greenlight for leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.
The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.
The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’ Ajovy (fremanezumab) to prevent migraine on Friday, September 16.
AstraZeneca and its research-and-development arm, MedImmune, announced that the U.S. FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) for adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous systemic therapies, including with a purine nucleoside analog.