FDA: Page 2

Departing FDA officials, WHO leaders argue against broad rollout of COVID-19 booster shots

Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed. 

By Ned Pagliarulo • Sept. 13, 2021

'The sky is not falling.' Cautious optimism follows FDA meeting on gene therapy risks

Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment.

By Ned Pagliarulo • Sept. 07, 2021

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.

By Ben Fidler • Sept. 07, 2021

At 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. 03, 2021

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. 01, 2021

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. 01, 2021

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 at 6:03 p.m.

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

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 at 3:16 p.m.

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

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

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 at 1:40 p.m.

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

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

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

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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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. 04, 2021

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. 02, 2021

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

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

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