FDA
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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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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.
Amry today announces that the US Food and Drug Administration (“FDA”) has granted Investigational New Drug (“IND”) clearance for AP101.