FDA: Page 2


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    Jens Schlueter via Getty Images

    FDA clears second COVID booster for older adults, immunocompromised

    "This was a relatively straightforward decision," top FDA official Peter Marks told reporters. The agency plans to discuss booster use more broadly with an advisory panel next month.

    By Updated March 29, 2022
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    Sarah Silbiger via Getty Images
    Deep Dive // ALS drug development

    How a long shot ALS drug came before the FDA

    A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision. 

    By March 28, 2022
  • Trendline

    The BioPharma Dive Outlook on 2022

    After surging into 2021, biotech crashed at the end of last year amid negative clinical trial readouts, ebbing M&A and broader investor pullback. But the year ahead figures to be busy on several fronts and a slate of important studies could deliver good news. 

    By BioPharma Dive staff
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    US curtails use of Vir, GSK's COVID-19 drug as omicron subvariant spreads

    The drug, found to be ineffective against a coronavirus strain known as BA.2, is no longer authorized for use in 10 states and U.S. territories, a limitation that could be widened further. 

    By March 28, 2022
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    Sarah Silbiger via Getty Images

    FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny

    The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.

    By March 25, 2022
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    Sarah Silbiger via Getty Images

    FDA, as expected, rejects Lilly and Innovent immunotherapy in signal to drugmakers

    The regulator demanded the partners run another clinical trial to support approval of sintilimab, a decision that could have ripple effects for the development and cost of cancer immunotherapies in the U.S.

    By March 24, 2022
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    Novartis

    Novartis wins FDA OK for radiopharmaceutical drug, cashing in on Endocyte deal

    The approval of Pluvicto for prostate cancer is a notable step forward for the field of radiopharmaceutical therapy and validates the Swiss drugmaker's $2.1 billion buyout of Endocyte in 2018.

    By Kristin Jensen • March 24, 2022
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    Sergio Flores via Getty Images

    Moderna, with new data, to seek clearance for COVID-19 vaccine in young children

    Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest. 

    By March 23, 2022
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers melanoma drug approved by FDA in immunotherapy advance

    Opdualag is first approved drug that works by targeting a protein called LAG-3 and the third type of "checkpoint inhibitor" the agency has cleared for cancer. 

    By March 21, 2022
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    Mario Tama via Getty Images

    Pfizer, BioNTech seek FDA clearance of 4th shot amid worries over next COVID wave

    The companies are forging ahead with plans to provide a second booster to people over 65, citing evidence, largely from observational studies in Israel, that diminishing protection may be restored with an additional shot.

    By March 16, 2022
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    Ewa Krawczyk, National Cancer Institute

    FDA clears AstraZeneca, Merck drug to treat some genetic breast cancers early

    Lynparza is the first drug targeting BRCA mutations to be approved for use in early breast cancer, a decision that could lead to more genetic testing.

    By March 14, 2022
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    Sarah Silbiger via Getty Images

    FDA panel to review once-rejected Acadia drug for psychosis

    The biotech company is making another attempt at expanding Nuplazid's use after an unexpected regulatory setback last year.

    By Kristin Jensen • March 10, 2022
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    Permission granted by Bristol-Myers Squibb

    In first, Bristol Myers wins FDA OK for Opdivo use before surgery in lung cancer

    Opdivo's approval is another step in drugmaker efforts to establish immunotherapy drugs earlier in cancer treatment.

    By March 7, 2022
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    Sarah Silbiger via Getty Images

    FDA sets back Karyopharm's bid to broaden use of cancer drug

    The biotech appeared poised to seek approval of its treatment, selinexor, in endometrial cancer. But regulators had a "differing" view of the data and requested another clinical trial.

    By Kristin Jensen • March 2, 2022
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    Mario Tama via Getty Images

    J&J, Legend cell therapy approved by FDA for multiple myeloma

    The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma.

    By Updated March 1, 2022
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    Sarah Silbiger via Getty Images

    FDA rejects Reata drug for rare kidney disease

    While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.

    By Feb. 28, 2022
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    DNY59 via Getty Images

    Lilly, Boehringer diabetes pill wins expanded use in heart failure

    The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.

    By Feb. 25, 2022
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    Warren Little via Getty Images

    Citing safety signal, GSK pauses some trials of new RSV vaccine

    As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.

    By Feb. 18, 2022
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers gets FDA decision date for earlier use of CAR-T therapy

    The FDA will decide whether to approve Bristol Myers' Breyanzi for second-line lymphoma treatment by late June, two months after it's set to make a similar decision for Gilead's Yescarta. 

    By Feb. 17, 2022
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    Win McNamee via Getty Images

    Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency

    Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.

    By Updated Feb. 15, 2022
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    Courtesy of Pfizer

    FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

    The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting that was scheduled for this week has been postponed as a result.

    By Feb. 11, 2022
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    Sarah Silbiger via Getty Images

    FDA sends signal with tough questions of Lilly at cancer drug meeting

    The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

    By Feb. 10, 2022
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    Sarah Silbiger via Getty Images

    Why the FDA is making a test case of a cancer drug from China

    The FDA appears unlikely to approve an immunotherapy developed by Eli Lilly and China's Innovent Biologics, citing issues with their trial data. A rejection, however, could shut out lower-cost competition.

    By , Updated Feb. 10, 2022
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    Courtesy of Sanofi

    Sanofi's Bioverativ deal begins to pay dividends with first new drug approval

    The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.

    By Feb. 7, 2022
  • Lilly slows FDA submission of Alzheimer's drug after Medicare decision

    Executives for the pharma downplayed the impact of an accelerated approval for donanemab, pointing to Medicare's plans to restrict coverage of Alzheimer's drugs like it to only patients in clinical trials.

    By Feb. 3, 2022
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    Sarah Silbiger via Getty Images

    First generic of top-selling eye drug Restasis approved by FDA

    At least nine generic drugmakers have tried to win approval of a lower-cost competitor to AbbVie's medicine, which has enjoyed market dominance for nearly two decades. Viatris is the first to succeed.

    By Kristin Jensen • Feb. 3, 2022