FDA: Page 30
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Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Jacob Bell/BioPharma Dive
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 -
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 -
Jacob Bell/BioPharma Dive
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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 -
Courtesy of BioNTech
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 -
Courtesy of Merck & Co.
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 -
Courtesy of Eli Lilly
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 -
Permission granted by Bristol-Myers Squibb
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. 5, 2021 -
Jacob Bell/BioPharma Dive
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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. 5, 2021 -
Permission granted by University of Maryland School of Medicine
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. 5, 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 -
Permission granted by Novartis
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
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 -
Courtesy of BioNTech
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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
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