FDA

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

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 at 11:03 a.m.

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

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

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 09, 2020

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 07, 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 06, 2020

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 at 5:03 p.m.

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

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

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 at 2:13 p.m.

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 09, 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 07, 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 07, 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 01, 2020