FDA: Page 18
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National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug
The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.
By Jonathan Gardner • July 6, 2022 -
Jacob Bell/BioPharma Dive
In 'unusual' move, FDA to reconvene advisers for ALS drug review
The drug’s developer, Amylyx Pharmaceuticals, said the meeting is scheduled for Sept. 7 and experts will discuss additional data analyses conducted since the last time the panel met.
By Jacob Bell • July 5, 2022 -
James Thew/stock.adobe.com
Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow
A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a potential lack of potency against new variants.
By Delilah Alvarado • June 30, 2022 -
Courtesy of Sanofi
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects
Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.
By Jonathan Gardner • June 30, 2022 -
Sarah Silbiger via Getty Images
5 FDA decisions to watch in the third quarter
Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as a cancer immunotherapy from Novartis.
By Ben Fidler , Ned Pagliarulo , Jacob Bell , Jonathan Gardner • June 29, 2022 -
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 Ben Fidler • June 23, 2022 -
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 Ned Pagliarulo , Ben Fidler • June 23, 2022 -
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 Ned Pagliarulo • Updated June 19, 2022 -
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 Ben Fidler • Updated June 15, 2022 -
Courtesy of Eli Lilly
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 -
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 Ben Fidler • Updated June 14, 2022 -
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 Jonathan Gardner , Ned Pagliarulo • June 13, 2022 -
Permission granted by Bluebird bio
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 Ned Pagliarulo • Updated June 10, 2022 -
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 Jonathan Gardner • Updated June 7, 2022 -
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 Ned Pagliarulo • June 3, 2022 -
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 Jonathan Gardner • May 23, 2022 -
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 Jacob Bell • May 17, 2022 -
Courtesy of Eli Lilly
Lilly wins FDA approval for new kind of diabetes drug
Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and was shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.
By Jonathan Gardner • Updated May 16, 2022 -
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 Ned Pagliarulo • May 13, 2022 -
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 Jonathan Gardner • May 10, 2022 -
AnnaStills via Getty Images
Sponsored by CorEvitasTraditional 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 -
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 Ben Fidler • May 6, 2022 -
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 Ben Fidler • May 5, 2022 -
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 Ben Fidler • May 4, 2022 -
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 Jonathan Gardner • May 2, 2022
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