FDA: Page 2

Merck, with new breast cancer data, aims to rebound from FDA rejection

Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.

By Ben Fidler • May 13, 2021

Heron, on third attempt, secures FDA approval for non-opioid painkiller

The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.

By Kristin Jensen • May 13, 2021

FDA unexpectedly grounds a gene therapy for a rare heart disease

Rocket Pharma's Danon disease treatment — key to the company's quiet rise over the past year — is the latest gene therapy to be put on hold by the agency. Executives predict only a short delay, however.

By Ben Fidler • May 11, 2021

FDA authorizes Pfizer's coronavirus vaccine for younger teens

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states begin to report waning demand. 

By Ned Pagliarulo • May 10, 2021

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.  

By Jonathan Gardner • May 07, 2021

FDA faces tough choice after panel backs speedy cancer drug approvals

FDA advisers last week recommended maintaining four of six accelerated immunotherapy approvals despite negative results in confirmatory testing.

By Ben Fidler , Ned Pagliarulo • April 30, 2021

Denying problems, AstraZeneca says US coronavirus vaccine filing due within weeks

Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.

By Jonathan Gardner • April 30, 2021

FDA gives first citation to biotech for failure to report clinical trial details

The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.

By Kristin Jensen • April 29, 2021

Lilly, citing FDA feedback, won't seek speedy approval of Alzheimer's drug

The drugmaker confirmed it won't try for accelerated approval of a closely watched Alzheimer's medicine based on a single Phase 2 trial. But it's planning a lengthy new study in presymptomatic patients. 

By Jonathan Gardner • April 27, 2021

FDA lifts hold on UniQure gene therapy study after review of cancer case

An investigation by UniQure determined the company's hemophilia gene therapy was "highly unlikely" to have caused a study volunteer's liver cancer, clearing the way for the FDA's green light.

By Jonathan Gardner • April 26, 2021

FDA, CDC support resuming use of J&J vaccine after advisory panel vote

While health officials have documented more cases of a rare blood clotting syndrome associated with J&J's vaccine, a CDC committee supported use of the shot with an added warning. 

By Ned Pagliarulo , Ben Fidler • UPDATED: April 23, 2021 at 7:14 p.m.

GSK immunotherapy wins FDA approval, joining crowded cancer drug class

Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others.

By Ned Pagliarulo • April 23, 2021

A look ahead at the FDA meeting that could decide the future of 6 cancer drug approvals

Accelerated approvals for immunotherapies from Merck, Bristol Myers Squibb and Roche might soon be withdrawn. Here's a detailed look at why.

By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • April 22, 2021

Lilly asks FDA to revoke clearance of first COVID-19 antibody drug

The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug.

By Ben Fidler • April 16, 2021

The US paused use of J&J's vaccine. What happens next?

A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.

By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • April 13, 2021

US recommends pause in J&J vaccinations due to concerns over rare blood clots

Regulators identified rare and serious blood clots in six women vaccinated with J&J's shot. The reaction resembles a side effect linked to AstraZeneca's vaccine.

By Ben Fidler , Ned Pagliarulo • UPDATED: April 13, 2021 at 11:02 a.m.

Cavazzoni to succeed Woodcock as the FDA's top drug reviewer

Cavazzoni will become director of CDER, a crucial position that Janet Woodcock, the FDA's acting commissioner and a contender for the full-time role, has filled for 24 of the last 27 years.

By Jonathan Gardner • April 12, 2021

Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application

While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.

By Jacob Bell • April 09, 2021

Gilead wins full approval for drug acquired in Immunomedics deal

Trodelvy, a key drug for Gilead's ambitions in oncology, is now fully approved to treat an aggressive, hard-to-treat form of breast cancer.

By Kristin Jensen • April 08, 2021

FDA pushes back decisions on skin disease and arthritis drugs from Pfizer, Lilly

The delays offer further evidence regulators remain wary of the safety issues surrounding so-called JAK drugs like Pfizer's Xeljanz and Lilly's Olumiant.

By Kristin Jensen • April 07, 2021

FibroGen admits misleading safety data for anemia drug, dimming prospects

In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review. 

By Ben Fidler • April 07, 2021

Acadia, with drug application rejected, calls out FDA for backtracking

According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.

By Jacob Bell • April 05, 2021

FDA advisers reassert case against approval of Biogen's Alzheimer's drug

In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time."

By Jacob Bell • March 31, 2021

FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer

Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.

By Ben Fidler • March 30, 2021

Akebia tries for FDA approval of anemia drug after mixed data

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

By Ned Pagliarulo • March 30, 2021