FDA: Page 30
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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 -
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 -
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 -
Jacob Bell/BioPharma Dive
AstraZeneca and Merck drug wins approval for rare cancer after failing elsewhere
Koselugo, as the drug will be sold, is now cleared to treat an inherited disorder that affects around one in 3,000 people in the U.S.
By Jonathan Gardner • Updated April 13, 2020 -
Eye drug side effects are real, Novartis confirms in new warning
A recent review by the Swiss pharma found Beovu caused potentially serious side effects about once in every 1,000 injections.
By Jonathan Gardner • April 9, 2020 -
FDA delays decision on Roche spinal muscular atrophy drug
Roche says the three-month delay is needed for the FDA to review new data for risdiplam, which could become the first oral option for the disabling and often fatal disorder.
By Jonathan Gardner • April 7, 2020 -
FDA's new Keytruda review is a step for genetic medicine, immunotherapy
A decision on approval, expected by June 16, would be the fourth tissue-agnostic drug approval — and could help to validate an emerging immunotherapy biomarker.
By Ben Fidler • April 7, 2020 -
Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug
Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen.
By Jonathan Gardner • April 1, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Under pressure, FDA touts speedy coronavirus drug development
By redeploying staff and request "triaging," the agency says it has streamlined its process for approving use of experimental drugs for COVID-19.
By Jonathan Gardner • April 1, 2020 -
With latest FDA submission, Bristol Myers keeps pace with Celgene milestones
Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year.
By Jonathan Gardner • March 31, 2020 -
Permission granted by Novartis
No sanctions for Novartis as FDA ends review of gene therapy violations
Quietly completing an inspection review, the FDA indicated it will not penalize Novartis for submitting altered data in its approval application for Zolgensma.
By Ned Pagliarulo • March 30, 2020 -
FDA clears emergency use of malaria pills to treat COVID-19
The unusual authorization, granted by the agency over the weekend, allows the federal government to distribute millions of doses of the drug to states.
By Ned Pagliarulo • March 30, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the 2nd quarter
The FDA's focus is squarely on responding to COVID-19, yet the agency continues to review new drugs for other diseases. Among them: Roche's SMA therapy risdiplam and Intercept's NASH drug.
By Jacob Bell , Ben Fidler • March 30, 2020 -
Despite another delay, Intercept says its NASH drug remains on track
The coronavirus outbreak, though, adds more uncertainty to what will be a closely watched regulatory review of Intercept's therapy.
By Ben Fidler • March 26, 2020 -
Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA
Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.
By Jonathan Gardner • March 26, 2020
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