FDA


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    Courtesy of Sarepta

    FDA suspends US testing of Sarepta Duchenne drug over safety concerns

    The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

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

    Bristol Myers CAR-T therapy cleared by FDA for earlier lymphoma use

    Breyanzi is now approved in the second-line setting, matching Gilead’s Yescarta, which won a similar clearance from the FDA earlier this year.

    By , June 23, 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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    Sarah Silbiger via Getty Images

    FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

    The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use.

    By Updated June 19, 2022
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    Sarah Silbiger via Getty Images

    FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

    Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

    By Updated June 15, 2022
  • FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

    The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch. 

    By Kristin Jensen • June 14, 2022
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    Alnylam Pharmaceuticals

    Alnylam wins FDA approval of rare disease drug in step toward profitability

    Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.

    By Updated June 14, 2022
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    Courtesy of Pfizer

    FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

    Agency advisers will weigh data from the companies at a two-day meeting that begins Tuesday with discussion of Moderna’s shot in children and teens aged 6 to 17 years old. Use in kids under 5 will be debated Wednesday. 

    By , June 13, 2022
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    FDA advisers offer unanimous support to second Bluebird gene therapy

    By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.

    By Updated June 10, 2022
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    Courtesy of Novavax, Australian Broadcasting Corporation

    FDA advisers back Novavax's latecomer COVID-19 vaccine

    Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.

    By Updated June 7, 2022
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    Sarah Silbiger via Getty Images

    FDA extends review of Amylyx ALS drug, delaying approval decision

    The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment. 

    By June 3, 2022
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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
  • 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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    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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    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