FDA: Page 25
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FDA clears Rocket to resume testing gene therapy for a rare heart disease
The decision from the regulator ends a three-month study pause that had stalled Rocket's development of the Danon disease treatment.
By Ben Fidler • Aug. 16, 2021 -
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CDC advisers back third dose of Pfizer, Moderna vaccines for immunocompromised people
The advisory panel's vote followed the FDA's authorization last Thursday of an additional dose for people with weakened immune systems.
By Shoshana Dubnow • Aug. 13, 2021 -
Sarah Silbiger via Getty Images
FDA authorizes third coronavirus vaccine dose for immunocompromised people
A CDC advisory panel is expected to vote on Friday to recommend the additional dose, after which certain people with weakened immune systems can receive a third shot of Pfizer's or Moderna's vaccine.
By Shoshana Dubnow • Aug. 13, 2021 -
Sarah Silbiger via Getty Images
FDA rejects FibroGen's kidney drug in major blow to company
While the decision was expected after a negative advisory panel last month, it's a significant setback that could trigger cost-cutting at the biotech, which said it will discuss next steps with partner AstraZeneca.
By Kristin Jensen • Aug. 11, 2021 -
Prasuwan, Worawut. Retrieved from Getty Images.
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Aug. 9, 2021 -
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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy
Acting FDA head Janet Woodcock asked for an investigation of the agency's decision to approve Biogen's Alzheimer's drug, but the inspector general's planned review appears to be more broadly aimed.
By Ned Pagliarulo , Jacob Bell • Aug. 4, 2021 -
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AstraZeneca wins first FDA approval for systemic lupus drug in a decade
The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.
By Jonathan Gardner • Aug. 2, 2021 -
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In a first, FDA approves an 'interchangeable' biosimilar for diabetes
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.
By Jonathan Gardner • July 29, 2021 -
Merck rebounds to win a milestone immunotherapy approval in early breast cancer
The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease.
By Ben Fidler • July 27, 2021 -
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Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues
With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.
By Ben Fidler • July 26, 2021 -
Sarah Silbiger via Getty Images
Ardelyx latest biotech surprised by unexpected FDA criticism of drug application
The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.
By Ben Fidler • July 20, 2021 -
Erik S. Lesser via Getty Images
Merck to take on Pfizer with FDA OK of next-gen pneumonia vaccine
Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.
By Jonathan Gardner • July 19, 2021 -
FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
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FDA flags rare side effect in new warning on J&J's coronavirus vaccine
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré.
By Jonathan Gardner • July 12, 2021 -
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FDA, under fire for Alzheimer's drug approval, seeks investigation of review process
Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.
By Ned Pagliarulo • Updated July 9, 2021 -
Permission granted by Biogen
FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment
Aduhelm's approval last month, already highly controversial, was made more so by the agency's decision to clear the drug for a broad group of patients. New prescribing information more closely matches clinical testing criteria.
By Ned Pagliarulo , Ben Fidler • July 8, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA decisions to watch in the third quarter
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm.
By Ned Pagliarulo , Ben Fidler • July 2, 2021 -
Permission granted by Biogen
Congress pressures FDA and Biogen on Alzheimer's drug approval, price
The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.
By Jonathan Gardner • June 28, 2021 -
FDA advisers vote down Incyte cancer drug as agency takes tougher line
The committee voted 13-4 to recommend the FDA wait for more clinical trial data from Incyte, which is aiming to win approval for what would be the eighth PD-1 or PD-L1 inhibitor.
By Ned Pagliarulo • June 25, 2021 -
Courtesy of Eli Lilly
Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug
The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.
By Ned Pagliarulo • Updated June 24, 2021 -
Sarah Silbiger via Getty Images
New Alzheimer's drugs
FDA documents show how controversial Alzheimer's drug decision was reached
A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug.
By Jacob Bell , Ned Pagliarulo • June 22, 2021 -
Jacob Bell/BioPharma Dive
Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
By Jacob Bell • June 16, 2021 -
Chip Somodevilla via Getty Images
Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
Sarah Silbiger via Getty Images
As trials progress, FDA weighs COVID-19 vaccine authorizations for children
An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.
By Jonathan Gardner • June 11, 2021 -
Permission granted by Biogen
The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.
Officially, Biogen has until 2029 to complete a study confirming Aduhelm's benefit. But the agency says it hopes to push the drugmaker to finish faster.
By Ned Pagliarulo • Updated June 9, 2021
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