FDA

Cavazzoni to succeed Woodcock as the FDA's top drug reviewer

Cavazzoni will become director of CDER, a crucial position that Janet Woodcock, the FDA's acting commissioner and a contender for the full-time role, has filled for 24 of the last 27 years.

By Jonathan Gardner • April 12, 2021

Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application

While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.

By Jacob Bell • April 09, 2021

Gilead wins full approval for drug acquired in Immunomedics deal

Trodelvy, a key drug for Gilead's ambitions in oncology, is now fully approved to treat an aggressive, hard-to-treat form of breast cancer.

By Kristin Jensen • April 08, 2021

FDA pushes back decisions on skin disease and arthritis drugs from Pfizer, Lilly

The delays offer further evidence regulators remain wary of the safety issues surrounding so-called JAK drugs like Pfizer's Xeljanz and Lilly's Olumiant.

By Kristin Jensen • April 07, 2021

FibroGen admits misleading safety data for anemia drug, dimming prospects

In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review. 

By Ben Fidler • April 07, 2021

Acadia, with drug application rejected, calls out FDA for backtracking

According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.

By Jacob Bell • April 05, 2021

FDA advisers reassert case against approval of Biogen's Alzheimer's drug

In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time."

By Jacob Bell • March 31, 2021

FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer

Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.

By Ben Fidler • March 30, 2021

Akebia tries for FDA approval of anemia drug after mixed data

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

By Ned Pagliarulo • March 30, 2021

5 FDA approval decisions to watch in the second quarter

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

By Ben Fidler , Jacob Bell , Jonathan Gardner • March 29, 2021

Pfizer and Lilly's pain drug hits setback in negative committee vote

In a Thursday meeting, advisers to the Food and Drug Administration concluded the companies didn't have a strong enough plan to mitigate the risks associated with tanezumab.

By Jacob Bell • March 26, 2021

FDA won't review Novo diabetes drug in latest case of regulatory pushback

Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.

By Ned Pagliarulo • March 23, 2021

AbbVie's approval delay raises further concerns about JAK drugs

An FDA request for more data, which comes on the heels of troubling results from a safety study of Pfizer's Xeljanz, could push back by three months AbbVie's plans to get Rinvoq approved in psoriatic arthritis.

By Jacob Bell • March 18, 2021

Lilly lays out 2-year plan to gain approval for Alzheimer's drug

Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.

By Jonathan Gardner • March 15, 2021

FDA sets meeting to review 6 speedy cancer drug approvals as evaluation widens

At a public hearing in April, the agency will ask a panel of experts whether three immunotherapies should remain on the market for certain cancer types, the latest step in an industrywide review.

By Ben Fidler • March 11, 2021

Acadia shares plunge after unexpected FDA feedback

According to Acadia, the FDA had said multiple times that there were no problems with its drug approval application. But last week, the agency surprisingly reversed course.

By Jacob Bell • March 09, 2021

Spurred by FDA review, Roche pulls Tecentriq for bladder cancer use

Four years after negative study results, the pharma withdrew the indication as the FDA's "industry-wide evaluation" of accelerated approvals progresses.

By Jonathan Gardner • March 08, 2021

FDA lays out data modernization action plan

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," wrote FDA leaders Janet Woodcock and Amy Abernethy.

By Nick Paul Taylor • March 04, 2021

Merck withdraws Keytruda in type of lung cancer amid 'industry-wide' review by FDA

Since December, three drugmakers have withdrawn immunotherapies from indications previously granted fast-tracked approvals, suggestive of broader FDA concerns.

By Ben Fidler • March 02, 2021

J&J's 1-dose coronavirus vaccine becomes third available in US

A CDC vaccine panel recommended use of the shot on Sunday following FDA authorization, and McKesson began shipping out doses to states Monday.

By Ned Pagliarulo • UPDATED: March 1, 2021 at 1:28 p.m.

FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization

In a unanimous vote, the panel of experts gave a green light to the FDA for clearing J&J's shot, judging the benefits of vaccination outweigh its risk.

By Ned Pagliarulo • UPDATED: March 1, 2021 at 1:33 p.m.

A play-by-play of the FDA meeting on J&J's vaccine

FDA advisers expressed growing comfort with the authorization process, offering unanimous support for J&J's shot. But the meeting also gave a window into debates likely to play out in the coming weeks and months.

By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • UPDATED: March 1, 2021 at 1:31 p.m.

FDA review supports safety, efficacy of J&J coronavirus vaccine

In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.

By Ned Pagliarulo , Jonathan Gardner • UPDATED: Feb. 24, 2021 at 11:45 a.m.

FDA lays out shortened path for testing vaccines against new coronavirus variants

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

By Ned Pagliarulo • Feb. 22, 2021

After FDA feedback, a biotech's ALS therapy faces murky path forward

Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.

By Jacob Bell • Feb. 22, 2021