FDA: Page 33
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Zogenix caps tumultuous ride with FDA OK for Dravet drug
The agency approved Zogenix's drug Fintepla after an earlier rejection and two delays, setting up potential commercial competition with GW Pharmaceuticals.
By Ben Fidler • Updated June 27, 2020 -
Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says
The agency has grappled with how to use real-world data in regulating drugs and medical devices, but is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said.
By Maria Rachal • June 19, 2020 -
With latest Keytruda approval, Merck beats Bristol Myers to a new immunotherapy target
The FDA decision validates a genetic cancer measure known as tumor mutational burden, which has been studied in multiple trials but previously never led to an approval.
By Ben Fidler • June 17, 2020 -
Jacob Bell/BioPharma Dive
FDA revokes emergency clearance for hydroxychloroquine, citing new data, risks
Negative results from two large studies in the U.S. and the U.K. factored into the regulator's reversal, which comes six weeks after it controversially authorized the malaria pill.
By Ned Pagliarulo • June 15, 2020 -
AstraZeneca spinout wins first FDA approval 2 years after launch
Viela Bio can now call itself a commercial-stage company, but its new drug Uplizna will compete with existing therapies in the rare neurological disease it just got approved to treat.
By Jonathan Gardner • June 12, 2020 -
Lilly wins first-ever FDA approval for drug that can spot Alzheimer's 'tau tangles'
Tauvid, which identifies the size and spread of tau protein clusters in the brain, could help Alzheimer's researchers as they shift away from a long-dominant focus on amyloid beta.
By Jacob Bell • May 29, 2020 -
Jacob Bell/BioPharma Dive
Contaminated diabetes drugs raise red flag for FDA oversight
The Food and Drug Administration is reaching out to drug manufacturers after finding some metformin pills were contaminated with the carcinogen NDMA.
By Jacob Bell • Updated May 29, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Intercept shares fall as FDA again delays closely watched NASH drug
The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.
By Jonathan Gardner • May 22, 2020 -
Sunovion crowds a new group of Parkinson's drugs, with uncertain sales prospects
Kynmobi has become the fourth drug the FDA has approved since late 2018 for the "off" episodes Parkinson's disease patients experience. The coronavirus pandemic may complicate an already challenging launch.
By Ben Fidler • May 22, 2020 -
AstraZeneca, Merck race past Clovis as PARPs break into prostate cancer
The approvals of Lynparza and Rubraca within days of one another mark the arrival of PARP inhibitors as treatments for prostate cancer — a role that could grow in the coming years.
By Ben Fidler • May 20, 2020 -
Bristol Myers, trailing Merck in lung cancer, finally wins FDA OK for immunotherapy combo
The long-sought approval of Opdivo and Yervoy gives Bristol Myers an entry into the competitive first-line lung cancer drug market after years of setbacks.
By Ben Fidler • May 18, 2020 -
Alex Wong via Getty Images
Ousted BARDA director: Hydroxychloroquine push distracted government scientists
Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday.
By Jonathan Gardner • May 14, 2020 -
Surprise setback for Bristol, Bluebird as FDA rejects cell therapy application
In a "refuse-to-file" letter, the regulator requested additional documentation of the companies' manufacturing processes for the CAR-T treatment, ide-cel.
By Ben Fidler , Ned Pagliarulo • May 13, 2020 -
Jacob Bell/BioPharma Dive
FDA, CDC drawing up plan to restart routine plant inspections
A phased approach is in the works to reintroduce oversight that's been on hold in the U.S. and abroad since March.
By Nick Paul Taylor • May 12, 2020 -
Courtesy of Eli Lilly
Lilly's Loxo buyout bears fruit as FDA clears cancer drug Retevmo
The pharma will launch Retevmo at a time when hospitals and academic centers are stretched thin by the COVID-19 pandemic.
By Ned Pagliarulo • May 9, 2020 -
Permission granted by Novartis
Novartis wins approval for niche lung cancer drug
Jumping ahead of competition, the Swiss pharma secured FDA clearance for Tabrecta, the first therapy targeted to certain mutations in a gene called MET.
By Jonathan Gardner • May 7, 2020 -
Another delay for Bristol Myers cell therapy as FDA extends review
Bristol Myers now expects an approval decision on liso-cel by mid-November, some six weeks before a deadline set by the pharma in its buyout of Celgene.
By Kristin Jensen • May 6, 2020 -
Permission granted by Gilead Sciences
Gilead's remdesivir, shown to hasten COVID-19 recovery, cleared for emergency use by FDA
In a remarkably rapid turn, the FDA authorized the antiviral drug two days after positive results were announced from a closely watched government-run clinical trial.
By Ned Pagliarulo • Updated May 1, 2020 -
Ewa Krawczyk, National Cancer Institute
Immunomedics wins long-sought FDA approval for breast cancer drug
Trodelvy, the first approved drug of Immunomedics' 38-year corporate history, was cleared by the FDA roughly five weeks ahead of schedule.
By Ned Pagliarulo • April 22, 2020 -
Biogen hammered with questions as Alzheimer's drug moves slower than expected
An application for aducanumab was supposed to be filed with the FDA early this year. Now, the biotech says it will finish doing so by the third quarter.
By Jacob Bell • April 22, 2020 -
LabCorp coronavirus test gets 1st FDA nod for at-home sample collection
The FDA re-issued an emergency authorization for the lab giant's molecular test, an OK that follows agency concerns about at-home diagnostics.
By Greg Slabodkin • April 21, 2020 -
Jacob Bell/BioPharma Dive
Seattle Genetics wins another speedy approval as FDA clears breast cancer drug
The FDA OK for Tukysa comes four months early and gives the biotech, which has seen its share price hit record highs, its third marketed cancer drug.
By Ben Fidler • April 17, 2020 -
NIH spearheads broad partnership with drugmakers, regulators to speed COVID-19 therapies
The initiative reflects the urgency for drugmakers to work together, rather than independently, to advance promising treatments for the novel coronavirus.
By Ben Fidler • April 17, 2020 -
As Ebola drug review starts, Regeneron hopes to chart similar path for coronavirus therapy
Technology used to develop the antibody cocktail for Ebola is now being tapped by Regeneron to ready a COVID-19 treatment for clinical testing.
By Ned Pagliarulo • April 16, 2020 -
Moderna's coronavirus vaccine plan may be possible, but a lot has to go in its favor
While Moderna has advanced rapidly in the month since this story was published, the biotech still faces many of the same challenges in the path to proving its vaccine.
By Ben Fidler • April 14, 2020
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