FDA
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Despite having achieved a record net sales of $477 million driven by the success of its powerhouse medication Adcetris in 2018, as well as a 58 percent increase in sales during the fourth quarter in comparison to the previous year, Seattle Genetics stock fell as the results did not meet analysts’ expectations.
Approval Based on Clinical Data from the PREMIER Trial - New Indication Provides Options for Patients with Small or Medium, Wide-Necked Brain Aneurysms
The U.S. Food and Drug Administration approved the first treatment for acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi’s Cablivi was given the greenlight and will become a cornerstone of the company’s new rare blood disorders franchise.
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.