FDA: Page 2

AstraZeneca, J&J cleared to restart major coronavirus vaccine studies

The U.S. trial of AstraZeneca's shot has been paused over safety concerns since early September, while J&J's was halted in mid-October. 

By Ned Pagliarulo • UPDATED: Oct. 24, 2020 at 2:59 p.m.

At key meeting, FDA advisors debate if early coronavirus vaccine approvals may compromise trials

An emergency clearance is expected for the first vaccine proven effective. But early availability of a shot could jeopardize ongoing studies, and may make tests of other candidates more difficult.

By Ned Pagliarulo • Oct. 23, 2020

Gilead's Veklury becomes first FDA-approved drug for COVID-19

The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.

By Ben Fidler • UPDATED: Oct. 23, 2020 at 10:05 a.m.

Lilly hires consultant to help fix issues at COVID-19 drug manufacturing plant

The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.  

By Kristin Jensen • Oct. 22, 2020

Q&A

Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

By Ben Fidler • Oct. 20, 2020

Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says

An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election. 

By Ben Fidler • Oct. 16, 2020

5 questions ahead of this week's FDA meeting on coronavirus vaccines

Normally staid affairs, this Thursday's advisory committee meeting will be closely watched and could set expectations for how the FDA will approach any future vaccine approval. 

By Jonathan Gardner • Oct. 16, 2020

FDA approves Regeneron antibody drug as first Ebola virus treatment

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

By Ned Pagliarulo • Oct. 14, 2020

Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug

While the committee's votes in favor of ALKS 3831 make an approval more likely, the drug's effects on patients also taking opioids could limit its use.

By Ben Fidler • Oct. 12, 2020

Regeneron follows Lilly in asking for emergency approval of COVID-19 antibody drug

The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.

By Ben Fidler • Oct. 08, 2020

FDA moves to pull preterm birth drug from market

AMAG Pharma, the maker of Makena, said the company disagreed with the FDA's proposal and plans to evaluate its options following a failed study.

By Kristin Jensen • Oct. 07, 2020

FDA releases coronavirus vaccine guidelines that White House resisted

The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely. 

By Ned Pagliarulo , Jonathan Gardner • Oct. 06, 2020

FDA told coronavirus vaccine makers of stricter standards for early approval

Blocked by the White House from issuing new vaccine guidelines, the FDA made its criteria for an emergency authorization clear anyway, publishing requirements it had previously communicated to drugmakers. 

By Ned Pagliarulo • UPDATED: Oct. 6, 2020 at 3 p.m.

Europe begins its 2nd coronavirus vaccine review as tension builds in US

The decision by European regulators to start speedy, "rolling" reviews of two vaccine candidates comes as the FDA and White House have reportedly been unable to agree on early approval standards.

By Ben Fidler • Oct. 06, 2020

Solid gets all-clear from FDA to restart gene therapy trial

Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.

By Jonathan Gardner • Oct. 01, 2020

5 FDA approval decisions to watch in the 4th quarter

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, are on the agency's agenda, too.

By Ned Pagliarulo , Ben Fidler • Sept. 29, 2020

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

Sponsored by Parexel International

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. 08, 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 at 11:30 a.m.

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. 02, 2020

Sponsored by Parexel Biotech

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