FDA

FDA panel, after debate, narrowly backs Merck COVID pill

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.

By Jonathan Gardner • Updated Nov. 30, 2021

New Merck study results raise questions about its COVID pill

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.

By Ben Fidler • Nov. 26, 2021

Takeda wins US approval for new CMV treatment

The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.

By Kristin Jensen • Nov. 24, 2021

Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

By Ben Fidler • Nov. 22, 2021

Biogen seeking more information in investigation of Aduhelm patient's death

A new report from an RBC investment analyst suggested the Alzheimer's drug played a role, adding to questions around the treatment's safety. 

By Ned Pagliarulo • Updated Nov. 19, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Soon after the FDA's authorization, a panel of CDC advisers followed with similar recommendations for third doses in adults over 18 years old. 

By Ben Fidler • Updated Nov. 20, 2021

Biden nominates Robert Califf to return as FDA head

If confirmed by Congress, the cardiologist would return to lead an agency facing weighty questions on COVID-19, a new user fee agreement and department staffing. 

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19. 

By Jonathan Gardner • Nov. 9, 2021

FDA extends review of J&J, Legend's cell therapy for multiple myeloma

The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.

By Jonathan Gardner , Ben Fidler • Nov. 2, 2021

Moderna faces delay in plans to bring coronavirus vaccine to US teenagers, young kids

The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S. 

By Ben Fidler • Nov. 1, 2021

FDA clears Pfizer's coronavirus vaccine for children, moving US to next stage of rollout

On a Friday press call, FDA leaders tried to allay the concerns of parents who might be hesitant to vaccinate their children, a key challenge facing public health officials.

By Shoshana Dubnow • Updated Nov. 1, 2021

FDA advisers support Pfizer's coronavirus vaccine for young children

Despite struggling with what some panelists called their toughest decision yet, the committee ultimately recommended COVID-19 vaccinations for 5- to 11-year-olds, which should pave the way for FDA authorization.

By Ned Pagliarulo • Oct. 26, 2021

A play-by-play of the FDA's meeting on Pfizer's vaccine for kids

Experts on the agency's panel dug into questions on the vaccine's safety in younger children, as well as uncertainty over how widely it should be used. Catch up on the discussion here. 

By Ben Fidler , Shoshana Dubnow , Jonathan Gardner • Updated Oct. 26, 2021

Roche's refillable eye implant becomes Eylea's latest threat

The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.

By Ben Fidler • Updated Oct. 25, 2021

What to watch at the FDA's high-stakes meeting on COVID-19 vaccines for kids

Documents released by the FDA Friday indicate agency staff are supportive of Pfizer's data, setting up an advisory panel meeting Tuesday that could open the door for an authorization in young children.

By Ben Fidler , Ned Pagliarulo • Updated Oct. 24, 2021

FDA authorizes additional Moderna, J&J shots, broadening booster rollout

The agency also cleared booster shots to be used interchangeably, though it did not provide specific recommendations. A CDC advisory committee meeting Thursday might provide further guidance.

By Shoshana Dubnow • Updated Oct. 21, 2021

Biden administration rolls out plan for vaccinating kids as FDA weighs clearance

The plan is dependent on FDA authorization and CDC recommendation of Pfizer's vaccine for children aged 5 to 11, expected by early next month.

By Shoshana Dubnow • Oct. 20, 2021

Sage, Biogen detail plans to get their newer depression drug approved

Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.

By Jacob Bell • Oct. 19, 2021

Biden reportedly weighing former FDA chief Califf to again lead agency

The Washington Post reported the administration was "closing in" on Califf, citing sources. The White House declined to comment and Califf could face opposition from Senate Democrats if chosen. 

By Ricky Zipp • Oct. 15, 2021

FDA advisers unanimously back Moderna booster shot for many Americans

But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear.

By Shoshana Dubnow • Oct. 14, 2021

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however. 

By Ned Pagliarulo • Oct. 14, 2021

NIH study finds mixing COVID-19 boosters increases immune response

Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.

By Shoshana Dubnow • Oct. 13, 2021

FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon. 

By Shoshana Dubnow • Oct. 13, 2021

Allogene cell therapy trials halted by FDA after unexpected safety finding

Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.

By Ben Fidler • Updated Oct. 8, 2021

Pfizer officially seeks FDA clearance for coronavirus vaccine in kids

The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.

By Shoshana Dubnow • Oct. 7, 2021