FDA: Page 2

FDA plans to restart domestic inspections, depending on local coronavirus trends

The agency aims to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.

By Maria Rachal • July 10, 2020

Biogen submitted its Alzheimer's drug for approval. Now what?

The later-than-expected filing is just the first of many hurdles Biogen faces in trying to get aducanumab approved. Some analysts on Wall Street don't have high hopes for the drug's chances.

By Jacob Bell • July 08, 2020

Merck hits rare FDA setback for cancer drug Keytruda

The regulator declined to grant a speedy approval for Keytruda and Lenvima in liver cancer, citing the recent clearance of another regimen.

By Kristin Jensen • July 08, 2020

5 FDA approval decisions to watch in the 3rd quarter

The next few months could bring approvals for BioMarin's hemophilia gene therapy, a spinal muscular atrophy drug from Roche and a DMD treatment from NS Pharma. 

By Ned Pagliarulo , Jonathan Gardner • July 08, 2020

FDA insists it 'will not cut corners' in coronavirus vaccine approvals

New guidelines released by the agency detail what reviewers will require from drugmakers before approving or making available any coronavirus vaccine. 

By Ned Pagliarulo • June 30, 2020

Intercept's NASH drug faces its biggest delay yet

The FDA rejected obeticholic acid, asking for more data. If the agency ends up requiring outcomes results too, it could set Intercept's approval hopes back by two years or more.

By Jacob Bell • June 29, 2020

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 at 11:20 a.m.

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

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

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