FDA

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Since December, three drugmakers have withdrawn immunotherapies from indications previously granted fast-tracked approvals, suggestive of broader FDA concerns.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

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

By Ben Fidler , Ned Pagliarulo • UPDATED: Feb. 23, 2021 at 9:28 p.m.

Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.

By Jonathan Gardner • Feb. 19, 2021

Novartis expects sales lift from expanded heart drug approval

The Swiss drugmaker's pill Entresto is now cleared in the U.S. for use in patients with stronger hearts, expanding the eligible population by two-thirds.

By Jonathan Gardner • Feb. 17, 2021

FDA advisers recommend agency wait on Keytruda approval in tough-to-treat breast cancer

More data are needed to support use of the immunotherapy before surgery in triple-negative breast cancer, according to the FDA advisory committee.

By Kristin Jensen • Feb. 10, 2021

FDA clears Lilly's COVID-19 antibody cocktail for emergency use

In a late-stage study of people recently diagnosed with COVID-19, the dual-antibody drug sharply reduced the risk of hospitalizations and death.

By Ned Pagliarulo • Feb. 10, 2021

Bristol Myers finally wins FDA approval for cancer cell therapy

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.

By Ned Pagliarulo , Ben Fidler • Feb. 05, 2021

FDA delays verdict for Biogen's closely watched Alzheimer's drug, raising investor optimism

Investors feared an outright rejection for aducanumab. But the FDA moving its approval deadline back three months is a signal to some that the agency wants to approve Biogen's drug.

By Jacob Bell • Jan. 29, 2021

Woodcock steps in as acting FDA chief with crucial vaccine decisions ahead

Coronavirus vaccine reviews and drug approval backlogs will be just some of the challenges the longtime FDA veteran will face as the agency awaits President Joe Biden’s permanent pick.

By Jonathan Gardner • Jan. 21, 2021

Merck, Bayer win FDA approval for heart failure drug

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.

By Kristin Jensen • Jan. 20, 2021

5 questions facing the FDA in 2021

A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.

By Jonathan Gardner • Jan. 14, 2021

5 FDA approval decisions to watch in the 1st quarter

Bristol Myers and Bluebird are awaiting an FDA decision on their multiple myeloma cell therapy ide-cel, and could also soon get news on their lymphoma CAR-T drug liso-cel.

By Jonathan Gardner , Ned Pagliarulo , Ben Fidler • Jan. 05, 2021

FDA says changing coronavirus vaccine dosing could put 'public health at risk'

In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature."

By Ben Fidler • Jan. 05, 2021

FDA grants approval to Ebola drug from Ridgeback

In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb. 

By Kristin Jensen • Dec. 22, 2020

FDA delays decision on Novartis cholesterol therapy

The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.

By Ned Pagliarulo • Dec. 21, 2020

Moderna's first FDA clearance brings the US a second coronavirus vaccine

The FDA's emergency authorization of the biotech's shot bolstered a nascent immunization campaign in the U.S.

By Ben Fidler • Dec. 18, 2020

FDA panel endorses Moderna's coronavirus vaccine

A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the FDA within days. 

By Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 6:02 p.m.

A play-by-play of the FDA meeting on Moderna's coronavirus vaccine

Members of an independent advisory committee voted 20-0 to recommend use of the company's experimental shot, paving the way for an emergency authorization from the FDA.

By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 5:42 p.m.

FDA scientists back safety, efficacy of Moderna's coronavirus vaccine

A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.

By Ned Pagliarulo • Dec. 15, 2020