FDA: Page 23
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Gene therapy safetyAt FDA meeting, gene therapy experts wrestle with field's blindspots
A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations.
By Ned Pagliarulo , Ben Fidler • Sept. 3, 2021 -
Sarah Silbiger via Getty Images
With safety worries mounting, FDA limits who can take certain immune-regulating drugs
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.
By Jacob Bell • Sept. 1, 2021 -
Sarah Silbiger via Getty Images
What to expect at the FDA's two-day meeting on gene therapy safety
A group of advisers convened by the agency began the two-day meeting Thursday with a discussion of cancer risk to AAV gene therapy.
By Ned Pagliarulo , Ben Fidler • Sept. 1, 2021 -
Sarah Silbiger via Getty Images
Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms
In a memo to agency staff, acting FDA head Janet Woodcock expressed confidence in the team that will remain in place under the leadership of CBER director Peter Marks.
By Ben Fidler • Updated Aug. 31, 2021 -
FDA scrutiny, Merck approval lead Roche to pull Tecentriq in breast cancer
While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication.
By Jonathan Gardner • Aug. 30, 2021 -
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FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine
During a press briefing, FDA officials expressed optimism the decision could help boost vaccination rates, but warned against off-label use — particularly in children, for which clinical tests are currently underway.
By Jonathan Gardner • Updated Aug. 23, 2021 -
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Biden said to rule out Woodcock as permanent FDA chief
A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving the FDA's top job in flux as key decisions near on coronavirus booster shots and vaccinations for children.
By Jonathan Gardner • Aug. 20, 2021 -
Courtesy of Eli Lilly
FDA approves Lilly, Boehringer diabetes drug for heart failure
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.
By Kristin Jensen • Aug. 19, 2021 -
Jens Schlueter via Getty Images
US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread
Top U.S. health officials defended their controversial decision to give all Americans a third shot, predicting that signs of lower efficacy against infection could lead to reduced protection against worse outcomes.
By Ned Pagliarulo , Ben Fidler • Updated Aug. 18, 2021 -
Courtesy of Eli Lilly
Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure
Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.
By Jonathan Gardner • Aug. 17, 2021 -
Merck wins approval for cancer drug acquired in 2019 biotech buyout
The FDA cleared Welireg, which Merck picked up in its $1 billion deal for Peloton Therapeutics, to treat tumors associated with a rare genetic disease.
By Ned Pagliarulo • Aug. 16, 2021 -
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 -
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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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Phill Magakoe via Getty Images
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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