FDA: Page 17
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Courtesy of Bluebird bio
Bluebird wins FDA approval of gene therapy for rare brain disorder
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million per patient.
By Ned Pagliarulo • Updated Sept. 17, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases
The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.
By Kristin Jensen • Sept. 15, 2022 -
Danielle Ternes/BioPharma Dive
BioMarin reports cancer case in hemophilia gene therapy trial
The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.
By Jonathan Gardner • Sept. 13, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets FDA approval for new type of psoriasis drug
Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.
By Jonathan Gardner • Updated Sept. 12, 2022 -
Sarah Silbiger via Getty Images
ALS drug developmentHow a top FDA official’s words helped push a closely watched ALS drug toward approval
Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review.
By Ned Pagliarulo • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA names new head to vaccine review office
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
By Jonathan Gardner • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back Amylyx ALS drug, reversing earlier position
Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.
By Jacob Bell • Updated Sept. 7, 2022 -
FDA holds back Alvotech’s Humira biosimilar over manufacturing issues
The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.
By Jonathan Gardner • Sept. 6, 2022 -
Courtesy of Sanofi
Sanofi, after long research journey, wins FDA approval for rare disease drug
Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.
By Kristin Jensen • Sept. 1, 2022 -
Sarah Silbiger via Getty Images
FDA clears updated COVID-19 boosters from Pfizer, Moderna
The new shots, which are designed to better target circulating strains of omicron, could be available within days.
By Delilah Alvarado • Aug. 31, 2022 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna follows Pfizer in asking FDA to approve updated COVID shot
The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.
By Kristin Jensen • Aug. 24, 2022 -
Carsten Koall via Getty Images
FDA authorizes Novavax’s COVID-19 vaccine for teens
The decision will make a third vaccine available for children 12 to 17 years old in the U.S., giving them an option that doesn’t use the messenger RNA technology of shots by Pfizer and Moderna.
By Christopher Newman • Updated Aug. 22, 2022 -
Mario Tama via Getty Images
Pfizer, BioNTech submit omicron booster for FDA clearance
The revamped shot, which is adapted to the omicron variants now circulating, is key to the Biden administration’s plans for a fall vaccination campaign.
By Ned Pagliarulo • Aug. 22, 2022 -
Sarah Silbiger via Getty Images
Pharvaris studies of rare disease drug put on hold by FDA
The agency suspended two trials of Pharvaris’ experimental treatment for hereditary angioedema after reviewing nonclinical data, the biotech said.
By Ned Pagliarulo • Aug. 22, 2022 -
koto_feja via Getty Images
Axsome rebounds to win FDA approval of depression drug
A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up.
By Ben Fidler • Aug. 19, 2022 -
Lisa Maree Williams via Getty Images
New Enhertu approval adds to growing role of well-known cancer target
AstraZeneca and Daiichi Sankyo’s drug is the first medicine cleared for lung tumors with mutations to HER2, a gene known for its link to breast cancers.
By Ben Fidler • Aug. 12, 2022 -
EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial
The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.
By Kristin Jensen • Aug. 11, 2022 -
Hollie Adams via Getty Images
US takes step to expand monkeypox vaccine supply
The FDA authorized a new plan that could lead to a five-fold increase in available doses. European health officials may follow the agency's lead.
By Kristin Jensen • Aug. 10, 2022 -
Stock via Getty Images
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
FDA, 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 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
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