FDA


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    Courtesy of Merck & Co.

    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 Updated Nov. 30, 2021
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    Courtesy of Merck & Co.

    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 Nov. 26, 2021
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    Dr_microbe via Getty Images

    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
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    Antonio Masiello via Getty Images

    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 Nov. 22, 2021
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    Biogen's new Alzheimer's drug

    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 Updated Nov. 19, 2021
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    Sarah Silbiger via Getty Images

    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 Updated Nov. 20, 2021
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    Win McNamee via Getty Images

    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 , Updated Nov. 12, 2021
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    Mario Tama via Getty Images

    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 Nov. 9, 2021
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    Mario Tama via Getty Images

    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 , Nov. 2, 2021
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    Carl Court via Getty Images

    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 Nov. 1, 2021
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    Sarah Silbiger via Getty Images

    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 Updated Nov. 1, 2021
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    Jacob Bell

    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 Oct. 26, 2021
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    Deep Dive

    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 , , Updated Oct. 26, 2021
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    Courtesy of Roche

    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 Updated Oct. 25, 2021
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    Lisa Maree Williams via Getty Images

    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 , Updated Oct. 24, 2021
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    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 Updated Oct. 21, 2021
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    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 Oct. 20, 2021
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    Getty Images

    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 Oct. 19, 2021
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    Win McNamee via Getty Images

    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
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    Gabriel Kuchta via Getty Images

    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 Oct. 14, 2021
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    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 Oct. 14, 2021
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    Jens Schlueter via Getty Images

    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 Oct. 13, 2021
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    Sarah Silbiger via Getty Images

    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 Oct. 13, 2021
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    Sarah Silbiger via Getty Images

    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 Updated Oct. 8, 2021
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    Spencer Platt via Getty Images

    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 Oct. 7, 2021