FDA


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    Courtesy of Pfizer

    Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

    The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

    By May 23, 2022
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    Permission granted by Gilead Sciences

    Gilead, having resolved manufacturing issues, forges ahead with HIV drug

    The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

    By May 17, 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
  • Lilly wins FDA approval for new kind of diabetes drug

    Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

    By Updated May 16, 2022
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    Sarah Silbiger via Getty Images

    BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers

    The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.

    By May 13, 2022
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    Sarah Silbiger via Getty Images

    With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

    The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.

    By May 10, 2022
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    AnnaStills via Getty Images
    Sponsored by CorEvitas

    Traditional and bespoke registries

    In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed. 

    May 9, 2022
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    Jon Cherry via Getty Images

    FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

    The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.

    By May 6, 2022
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    Jacob Bell / BioPharma Dive

    AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche

    The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.

    By May 5, 2022
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    utah778 via Getty Images

    Spero to lay off 75% of workforce, change strategy after FDA challenges study results

    Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.

    By May 4, 2022
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    Sarah Silbiger via Getty Images

    FDA rejects two China-developed cancer drugs

    The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

    By May 2, 2022
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    Monty Rakusen via Getty Images
    Sponsored by CorEvitas

    Understanding real-world data in the real world

    Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond. 

    May 2, 2022
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    Sergio Flores via Getty Images

    Moderna seeks FDA clearance for COVID-19 vaccine in young children

    The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination. 

    By Kristin Jensen • April 28, 2022
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    Sarah Silbiger via Getty Images

    FDA panel supports agency push to raise approval bar for certain cancer drugs

    Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.

    By April 22, 2022
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    Sarah Silbiger via Getty Images

    GSK to test FDA's tough stance on anemia pills

    Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.

    By April 19, 2022
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    Jacob Bell / BioPharma Dive

    Troubling data leads a biotech to pull its prized drug from market and FDA review

    Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

    By April 18, 2022
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    Courtesy of Pfizer

    Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

    A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.

    By Kristin Jensen • April 14, 2022
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    Justin Sullivan via Getty Images

    FDA clears Gilead to restart some studies of top cancer drug

    The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.

    By April 12, 2022
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    Sarah Silbiger via Getty Images

    'Where's the patient?': Experts question FDA's device recall guidance

    While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.

    By Ricky Zipp • April 6, 2022
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    Sergio Flores via Getty Images

    FDA advisers grapple with how to update COVID-19 vaccines

    About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

    By Updated April 7, 2022
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    Sarah Silbiger via Getty Images

    FDA halts Vir, GSK antibody use in response to COVID subvariant's spread

    The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.

    By Kristin Jensen • April 6, 2022
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    Getty Images

    Novartis breast cancer drug approved for ultra-rare condition

    The FDA's decision was based on real-world study data that indicated Novartis' Piqray could treat a cluster of conditions known collectively as PROS.

    By April 6, 2022
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    Gilead Sciences Inc.

    CAR-T treatment moves earlier as FDA widens approval of Gilead's Yescarta

    Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.

    By April 4, 2022
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    Sarah Silbiger via Getty Images

    5 FDA decisions to watch in the second quarter

    While a market downturn has weighed on the biotech industry, FDA approvals for drugs from Bristol Myers Squibb, Bluebird bio and Amylyx Pharmaceuticals could help the sector regain its footing.

    By , , March 31, 2022
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    ismagilov via Getty Images

    FDA rejects Akebia drug, dealing another blow to anemia pills

    The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.

    By March 30, 2022
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    Sarah Silbiger via Getty Images
    ALS drug development

    FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances

    The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.

    By Updated March 30, 2022