FDA
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FDA approves AstraZeneca, Daiichi drug in breast cancer first
Enhertu is the first targeted therapy cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.
By Ned Pagliarulo • Aug. 5, 2022 -
Sarah Silbiger via Getty Images
Acadia turned back by FDA on second attempt to get psychosis drug approved
The agency issued Acadia a complete response letter for pimavanserin, for which the company had sought to win an expanded clearance in Alzheimer’s disease psychosis.
By Ned Pagliarulo • Aug. 5, 2022 -
Hollie Adams via Getty Images
FDA signs off on Bavarian Nordic plant, allowing distribution of monkeypox vaccine doses
The agency’s decision means hundreds of thousands of additional doses can be made available in the U.S., which now accounts for the most cases globally.
By Kristin Jensen • July 28, 2022 -
Permission granted by Biogen
ALS drug developmentFDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug
Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.
By Jacob Bell • July 26, 2022 -
Novartis
Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug
Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.
By Jonathan Gardner • July 25, 2022 -
Sarah Silbiger via Getty Images
AstraZeneca, Daiichi breast cancer drug set for speedy FDA review
The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.
By Ned Pagliarulo • July 25, 2022 -
Sarah Silbiger via Getty Images
Novartis, BeiGene cancer drug faces delay as FDA puts off approval decision
The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.
By Ned Pagliarulo • July 14, 2022 -
Carsten Koall via Getty Images
FDA clears Novavax's COVID-19 vaccine as 4th option in US
The shot is the first of its type authorized for COVID-19 by the FDA, but faces an uncertain future due to questions about its ability to fight omicron as well as the biotech’s ability to manufacture large quantities.
By Jonathan Gardner • Updated July 13, 2022 -
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 -
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 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 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
