FDA

Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating. 

By Delilah Alvarado • Sept. 26, 2022

FDA user fee package to be included in bill to fund government, avoid shutdown, senators say

A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.

By Elise Reuter • Sept. 23, 2022

FDA advisers back microbiota-based treatment for gut infection

Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no approved options after antibiotics fail.

By Christopher Newman • Updated Sept. 23, 2022

Lilly drug wins FDA clearance for gene-mutated solid tumors, regardless of type

The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.

By Kristin Jensen • Sept. 22, 2022

Fennec wins approval of first drug for chemotherapy-induced hearing loss in children

The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators. 

By Christopher Newman • Sept. 21, 2022

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

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

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

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

How 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

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

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

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 Kristen Jensen • Sept. 1, 2022

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

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 Kristen Jensen • Aug. 24, 2022

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

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

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

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

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

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

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

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