FDA

HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

Acting FDA head Janet Woodcock asked for an investigation of the agency's decision to approve Biogen's Alzheimer's drug, but the inspector general's planned review appears to be more broadly aimed. 

By Ned Pagliarulo , Jacob Bell • Aug. 04, 2021

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

By Jonathan Gardner • Aug. 02, 2021

In a first, FDA approves an 'interchangeable' biosimilar for diabetes

An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs. 

By Jonathan Gardner • July 29, 2021

Merck rebounds to win a milestone immunotherapy approval in early breast cancer

The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease. 

By Ben Fidler • July 27, 2021

Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues

With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.

By Ben Fidler • July 26, 2021

Ardelyx latest biotech surprised by unexpected FDA criticism of drug application

The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.

By Ben Fidler • July 20, 2021

Merck to take on Pfizer with FDA OK of next-gen pneumonia vaccine

Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.

By Jonathan Gardner • July 19, 2021

FDA advisers push back on FibroGen anemia drug

Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.

By Jonathan Gardner • July 16, 2021

FDA flags rare side effect in new warning on J&J's coronavirus vaccine

The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré. 

By Jonathan Gardner • July 12, 2021

FDA, under fire for Alzheimer's drug approval, seeks investigation of review process

Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.

By Ned Pagliarulo • UPDATED: July 9, 2021 at 3:20 p.m.

FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment

Aduhelm's approval last month, already highly controversial, was made more so by the agency's decision to clear the drug for a broad group of patients. New prescribing information more closely matches clinical testing criteria.

By Ned Pagliarulo , Ben Fidler • July 08, 2021

5 FDA decisions to watch in the third quarter

The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm.

By Ned Pagliarulo , Ben Fidler • July 02, 2021

Congress pressures FDA and Biogen on Alzheimer's drug approval, price

The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.

By Jonathan Gardner • June 28, 2021

FDA advisers vote down Incyte cancer drug as agency takes tougher line

The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.

By Ned Pagliarulo • June 25, 2021

Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug

The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.

By Ned Pagliarulo • UPDATED: June 24, 2021 at 10:08 a.m.

FDA documents show how controversial Alzheimer's drug decision was reached

A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug. 

By Jacob Bell , Ned Pagliarulo • June 22, 2021

Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

By Jacob Bell • June 16, 2021

Former FDA chief Hahn joins venture firm that launched Moderna

Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors. 

By Jonathan Gardner • June 15, 2021

As trials progress, FDA weighs COVID-19 vaccine authorizations for children

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.

By Jonathan Gardner • June 11, 2021

The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.

By Ned Pagliarulo • UPDATED: June 9, 2021 at 10:33 a.m.

Deep Dive

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

With the decision, the agency cleared the way for what many predict will become a lucrative and sought-after option — though fierce debate continues over whether Biogen's aducanumab actually benefits patients' daily lives.

By Jacob Bell • UPDATED: June 7, 2021 at 3:30 p.m.

Former FDA official Abernethy joins Google health spinoff

The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.

By Jonathan Gardner • June 03, 2021

Alkermes prepares for uncertain launch as FDA finally clears schizophrenia drug

Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.

By Jacob Bell • June 01, 2021

In first, FDA approves KRAS-blocking cancer drug from Amgen

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.

By Ned Pagliarulo • UPDATED: May 29, 2021 at 12:35 p.m.

FDA restricts use of Intercept drug due to liver injury risk

An investigation linked the drug to severe injuries in about two dozen patients, leading the agency to add a new contraindication to the label.

By Kristin Jensen • May 27, 2021