FDA: Page 2

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

Regeneron pauses studies of a key cancer drug, citing safety concerns

The FDA flagged a high rate of cytokine release syndrome, a potentially dangerous side effect, in trials of a lymphoma drug Regeneron is developing.

By Kristin Jensen • Dec. 15, 2020

In historic decision, FDA clears coronavirus vaccine from Pfizer, BioNTech

The vaccine was the first authorized for emergency use in the U.S. after a large study showed it to be highly protective against COVID-19, a landmark moment amid a worsening pandemic.

By Jonathan Gardner • Dec. 11, 2020

FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

In a statement Friday, FDA Commissioner Stephen Hahn said the agency would "rapidly work toward finalization and issuance" of an authorization for the shot.

By Ned Pagliarulo • UPDATED: Dec. 11, 2020 at 10:32 a.m.

A play-by-play of the historic FDA meeting on Pfizer and BioNTech's coronavirus vaccine

A panel of vaccine and infectious disease experts met Thursday to public vet the drugmaker's study results, eventually voting 17-4 in support of the vaccine after nearly nine hours of discussion. 

By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • UPDATED: Dec. 9, 2020 at 7:01 p.m.

FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine

Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.

By Ned Pagliarulo • UPDATED: Dec. 8, 2020 at 2:48 p.m.

Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use

The drug is the second antibody-based treatment to win FDA emergency authorization this month, though supplies of both are very limited.

By Ben Fidler • Nov. 22, 2020

Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine

The companies expect immunizations with their shot, if approved, could begin in high-risk groups by the middle to end of December. 

By Ned Pagliarulo • UPDATED: Nov. 20, 2020 at 6:11 p.m.