FDA: Page 15
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5 FDA decisions to watch in the first quarter
An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.
By Ben Fidler , Ned Pagliarulo , Jonathan Gardner , Delilah Alvarado • Jan. 9, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022
The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.
By Ned Pagliarulo • Jan. 3, 2023 -
Sarah Silbiger via Getty Images
FDA approval of Biogen Alzheimer’s drug was ‘rife with irregularities,’ congressional report says
An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline.”
By Jonathan Gardner • Dec. 30, 2022 -
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FDA sets decision date for Alvotech’s Humira biosimilar
Along with the review deadline, Alvotech also disclosed the FDA had turned back an application for interchangeability as the agency needs to reinspect a manufacturing facility.
By Jonathan Gardner • Dec. 22, 2022 -
Lisa Maree Williams via Getty Images
Europe broadens Lynparza use as FDA ups scrutiny of PARP drugs
Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers.
By Ben Fidler • Dec. 21, 2022 -
Megan Quinn/BioPharma Dive
Government spending bill would tighten FDA oversight of accelerated drug approvals
The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.
By Jonathan Gardner • Dec. 20, 2022 -
Sarah Silbiger via Getty Images
Ferring wins FDA approval for bladder cancer gene therapy
The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.
By Delilah Alvarado • Dec. 19, 2022 -
Sarah Silbiger via Getty Images
Another Humira biosimilar approved by FDA as AbbVie patent expiry looms
Fresenius Kabi is getting ready for a July launch in the U.S. of its copycat version, called Idacio, four years after it began sales in other countries.
By Kristin Jensen • Dec. 15, 2022 -
Sarah Silbiger via Getty Images
Cytokinetics heart drug voted down by FDA panel
Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took issue with its trial evidence.
By Delilah Alvarado • Dec. 14, 2022 -
Sarah Silbiger via Getty Images
Mirati’s KRAS-blocking cancer drug approved by FDA
Cleared for a certain kind of mutated lung cancer, the medicine will challenge Amgen’s similarly acting treatment Lumakras.
By Ned Pagliarulo • Dec. 13, 2022 -
Gabriel Kuchta via Getty Images
FDA clears updated omicron boosters for youngest children
Pfizer's reformulated vaccine is now authorized for children 6 months to 4 years of age who have not completed its primary series, while Moderna's updated shot is cleared as a booster for those 6 months to 5 years old.
By Christopher Newman • Dec. 9, 2022 -
Sarah Silbiger via Getty Images
MEI, Kyowa stop lymphoma drug trials after FDA meeting
The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors.
By Jonathan Gardner • Dec. 6, 2022 -
Seth Babin/BioPharma Dive
Verve shares slide after company reveals details on FDA trial hold
In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.
By Delilah Alvarado • Dec. 6, 2022 -
Sarah Silbiger via Getty Images
Rigel wins US approval of rival drug to Servier leukemia treatment
The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.
By Christopher Newman • Dec. 2, 2022 -
Sarah Silbiger via Getty Images
FDA approves first microbiota-based treatment
The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.
By Christopher Newman • Dec. 1, 2022 -
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Roche pulls Tecentriq in bladder cancer, completing sweep of ‘dangling’ accelerated approvals
The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.
By Jonathan Gardner • Nov. 29, 2022 -
Sarah Silbiger via Getty Images
Spectrum to lay off R&D staff after FDA drug rejection
The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.
By Delilah Alvarado • Nov. 28, 2022 -
Courtesy of Sarepta
FDA grants speedy review to Sarepta’s Duchenne gene therapy
The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.
By Jonathan Gardner • Nov. 28, 2022 -
ismagilov via Getty Images
FDA approves first gene therapy for hemophilia B
The one-time treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million per infusion.
By Ned Pagliarulo • Updated Nov. 23, 2022 -
Courtesy of GSK
GSK to pull blood cancer drug from US market after study failure
The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.
By Ned Pagliarulo • Nov. 22, 2022 -
Sarah Silbiger via Getty Images
First-of-its-kind Type 1 diabetes drug wins FDA approval
Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen.
By Delilah Alvarado • Nov. 18, 2022 -
Courtesy of Eli Lilly
FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar
Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus.
By Christopher Newman • Nov. 18, 2022 -
Sarah Silbiger via Getty Images
FDA panel votes in favor of Ardelyx’s once-rejected kidney disease drug
The recommendation represents a surprising turnaround for Ardelyx’s drug, which the FDA put before an advisory committee only after the biotech appealed its rejection last year.
By Kristin Jensen • Nov. 17, 2022 -
For ImmunoGen, persistence pays off as FDA clears ovarian cancer drug
The approval makes Elahere the first wholly owned medicine the biotech has brought to market in its lengthy history.
By Jonathan Gardner • Nov. 15, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Moderna data supports use of omicron booster over original vaccine
New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.
By Jonathan Gardner • Nov. 14, 2022
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