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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Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.
Pharnext SA announced that the U.S. Food and Drug Administration has granted Fast Track designation for the development of PXT3003 for the treatment of patients with Charcot-Marie-Tooth disease Type 1A.
Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
The approval of the combination marks a first for the U.S. market. The combination of AbbVie and Janssen’s Imbruvica with Roche’s Gazyva is the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy, AbbVie said this morning.
Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
Biom’up has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
The partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).