FDA: Page 29
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Courtesy of Merck & Co.
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 -
Jacob Bell/BioPharma Dive
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 -
Courtesy of Eli Lilly
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 9, 2021 -
Permission granted by Roche
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 8, 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 4, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 2, 2021 -
Permission granted by Johnson & Johnson
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 -
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 -
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
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