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

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Accelerated approvals for immunotherapies from Merck, Bristol Myers Squibb and Roche might soon be withdrawn.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

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 9, 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 8, 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 7, 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 7, 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 5, 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

5 FDA approval decisions to watch in the second quarter

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

By Ben Fidler , Jacob Bell , Jonathan Gardner • March 29, 2021

Pfizer and Lilly's pain drug hits setback in negative committee vote

In a Thursday meeting, advisers to the Food and Drug Administration concluded the companies didn't have a strong enough plan to mitigate the risks associated with tanezumab.

By Jacob Bell • March 26, 2021

FDA won't review Novo diabetes drug in latest case of regulatory pushback

Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.

By Ned Pagliarulo • March 23, 2021

AbbVie's approval delay raises further concerns about JAK drugs

An FDA request for more data, which comes on the heels of troubling results from a safety study of Pfizer's Xeljanz, could push back by three months AbbVie's plans to get Rinvoq approved in psoriatic arthritis.

By Jacob Bell • March 18, 2021

Lilly lays out 2-year plan to gain approval for Alzheimer's drug

Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.

By Jonathan Gardner • March 15, 2021

FDA sets meeting to review 6 speedy cancer drug approvals as evaluation widens

At a public hearing in April, the agency will ask a panel of experts whether three immunotherapies should remain on the market for certain cancer types, the latest step in an industrywide review.

By Ben Fidler • March 11, 2021