Biogen's all-important Alzheimer's drug enters the review gauntlet

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.

By Jacob Bell • Sept. 29, 2020

Trump undercuts FDA on coronavirus vaccine authorization plans

The president suggested his administration may not sign off on FDA plans to spell out standards for authorizing a coronavirus vaccine, again raising concerns about political interference.

By Ned Pagliarulo • Sept. 24, 2020

FDA decision on Bristol Myers cell therapy could come down to the wire

An FDA decision on Bristol Myers' myeloma treatment ide-cel could come four days before a key deadline related to the pharma's buyout of Celgene. 

By Jonathan Gardner • Sept. 22, 2020

Keys to success when interacting virtually with health authorities

Due to COVID-19, health authority meetings are now virtual. Learn how you can flourish in this arena. 

By Parexel International • Sept. 22, 2020

Seattle Genetics stays step ahead of rivals with bladder cancer data

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

By Jonathan Gardner • Sept. 18, 2020

Coronavirus vaccine makers vow to wait for data before seeking approval

In an unusual letter, the heads of nine top vaccine developers pledged to "stand with science" and only move forward with approval applications if warranted by clinical results.

By Ben Fidler • Sept. 8, 2020

FDA scolds Mylan for 'repeated' manufacturing problems

Though it once had a glimmering manufacturing record, Mylan now finds itself in the crosshairs of the FDA. The agency is advising the company to quickly and comprehensively assess its global operations.

By Jacob Bell • Updated Sept. 4, 2020

NIH panel says data doesn't support plasma use for COVID-19

The expert advisers' determination appears to conflict with a decision by the FDA last week to clear the blood-derived treatment for emergency use.

By Ned Pagliarulo • Sept. 2, 2020

Top 10 myths about working with the FDA for an oncology drug approval

Debunking myths around working with the FDA for oncology drug approval. 

By Amy McKee, Vice President Regulatory Consulting Services, Parexel • Aug. 31, 2020

Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

By Greg Slabodkin • Aug. 27, 2020

Sarepta, after two dramatic approvals, gets an FDA review for next Duchenne drug

Sarepta's first two medicines were both cleared in controversial fashion. Will its third attempt go more smoothly?

By Jonathan Gardner • Aug. 25, 2020

FDA ends pressure-packed weekend with emergency OK for blood-derived COVID-19 treatment

Following criticism, FDA commissioner Stephen Hahn clarified his comments about the potential effectiveness of convalescent plasma against COVID-19. 

By Ben Fidler • Updated Aug. 25, 2020

Novartis set to take on Roche as FDA clears first at-home, injectable MS drug

Kesimpta, a new multiple sclerosis drug from Novartis, works the same way as Roche's blockbuster Ocrevus, but patients can take it without leaving home.

By Ben Fidler • Aug. 20, 2020

BioMarin's gene therapy rejection didn't shock everyone

The FDA's decision not to approve Roctavian raises the question of why BioMarin was able to submit the hemophilia A therapy in the first place.

By Jacob Bell • Aug. 20, 2020

In major surprise, FDA rejects high-profile therapies from BioMarin, Gilead

BioMarin's hemophilia gene therapy Roctavian and Gilead's arthritis drug filgotinib were widely expected to win approvals from the FDA, which demanded more study data from both drugmakers.

By Ned Pagliarulo , Ben Fidler , Jacob Bell • Updated Aug. 19, 2020

Roche wins FDA approval for first self-administered biologic for rare eye disease

Enspryng is the second drug OK'd in three months for an autoimmune disorder that causes blindness and impaired mobility, but it's the only one that patients can take at home.

By Jonathan Gardner • Aug. 17, 2020

FDA gives speedy approval to another Duchenne drug

The nod for NS Pharma's Viltepso is the third time the agency has cleared a Duchenne drug based on the likelihood, rather than proof, it can help patients.

By Ben Fidler • Updated Aug. 13, 2020

First liquid biopsy test that uses advanced gene sequencing approved by FDA

The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test.

By Susan Kelly • Aug. 10, 2020

First oral drug for spinal muscular atrophy approved by FDA

Roche priced Evrysdi below the cost of competing treatments from Novartis and Biogen, but the drug's list price still tops $100,000 for many patients.

By Ben Fidler • Aug. 7, 2020

FDA agrees to review Biogen's Alzheimer's drug

The agency's decision kicks off a historic and dramatic regulatory review, as significant lingering questions surround aducanumab's approval chances.

By Jacob Bell • Aug. 7, 2020

Advancing cardiac care through health information technology

A talk with the American College of Cardiology about how they are working with Health IT to deliver their guidance to the point-of-care. 

Aug. 6, 2020

FDA rejects a peanut allergy treatment, sinking a small biotech's shares

Given the long list of requirements in the FDA's rejection letter, DBV Technologies likely has years of work ahead to win approval of Viaskin Peanut.

By Jacob Bell • Aug. 4, 2020

AstraZeneca signals it won't wait for US data to seek clearance of coronavirus vaccine

The British drugmaker indicated on a conference call that data from trials already underway in the U.K., Brazil and South Africa will be sufficient to ask regulators to approve the vaccine.  

By Jonathan Gardner • July 30, 2020

Bristol Myers resubmits cancer cell therapy, lifting investors' chance at payout

A surprise refusal by the FDA in May to review Bristol Myers' application put at risk a conditional payment promised as part of the pharma's Celgene deal.

By Ben Fidler • July 29, 2020

Side effects don't stop FDA panel from backing GSK blood cancer drug

An approval decision on what could be a first-in-class multiple myeloma drug is due this month, but the FDA will need to weigh safety concerns against the panel's unanimous support.

By Jonathan Gardner • July 15, 2020