FDA: Page 25
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Courtesy of Eli Lilly
Lilly drug becomes first COVID antibody cleared for use in young children
The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.
By Jonathan Gardner • Dec. 6, 2021 -
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 Jonathan Gardner • Updated Nov. 30, 2021 -
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 Ben Fidler • Nov. 26, 2021 -
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 -
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 Ben Fidler • Nov. 22, 2021 -
Permission granted by Biogen
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 -
Sarah Silbiger via Getty Images
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
A monthslong process of authorizing booster shots for vulnerable Americans culminated in the FDA's Nov. 19 decision to open eligibility for all adults, now all the more critical with omicron's spread.
By Ben Fidler • Updated Nov. 20, 2021 -
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 Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021 -
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 Jonathan Gardner • Nov. 9, 2021 -
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 Jonathan Gardner , Ben Fidler • Nov. 2, 2021 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by 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 Ben Fidler • Nov. 1, 2021 -
Sarah Silbiger via Getty Images
FDA clears Pfizer's coronavirus vaccine for children, moving US to next stage of rollout
The late October authorization opened up access to COVID-19 vaccines for millions of children between 5 and 11 years old in a major relief for parents after a difficult year.
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 -
Justin Sullivan via Getty Images
Deep DiveA 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 -
Permission granted by 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 Ben Fidler • Updated Oct. 25, 2021 -
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 Ben Fidler , Ned Pagliarulo • Updated Oct. 24, 2021 -
Sergio Flores via Getty Images
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 -
Drew Angerer via Getty Images
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 -
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 -
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 Shoshana Dubnow • Oct. 14, 2021 -
Jacob Bell/BioPharma Dive
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 -
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 Shoshana Dubnow • Oct. 13, 2021 -
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 Shoshana Dubnow • Oct. 13, 2021 -
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 Ben Fidler • Updated Oct. 8, 2021
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