Merck gets a ‘surprise’ win for Keytruda in early lung cancer

The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main supporting study, taking one Wall Street analyst by surprise. 

By Ben Fidler • Jan. 27, 2023

FDA advisers back agency plan to simplify COVID-19 vaccination

The expert committee supported making primary and booster shots the same composition, while recommending periodic updates to better match the vaccines to circulating variants.

By Ned Pagliarulo , Jonathan Gardner • Updated 5 hours ago

FDA advisers back Cidara and Melinta’s antifungal treatment

The drug, if approved, would be the first new treatment in more than a decade for two conditions that stem from Candida fungus.

By Kristin Jensen • Jan. 25, 2023

FDA weighs shift in COVID vaccination strategy

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

By Ned Pagliarulo • Jan. 23, 2023

Why Wall Street shrugged at Lilly’s Alzheimer’s setback

Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

By Jacob Bell • Jan. 20, 2023

FDA lifts hold on Astellas gene therapy for Pompe disease

The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

By Christopher Newman • Jan. 20, 2023

FDA rejects Lilly Alzheimer’s drug, citing insufficient data

The drugmaker had sought an accelerated approval based on data from a small mid-stage trial. Results from a larger study are due in the second quarter.

By Ned Pagliarulo • Jan. 20, 2023

JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas

Venture investors cautioned of a coming funding crunch for young biotechs, while the FDA commissioner shared advice for drugmakers.

By Jacob Bell , Gwendolyn Wu , Ned Pagliarulo • Jan. 10, 2023

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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