FDA: Page 28
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Courtesy of Eli Lilly
Coronavirus variants threaten to undermine another Lilly COVID-19 drug
One month after Lilly's first coronavirus antibody was pulled from market, the U.S. government stopped distributing its other treatment in two states.
By Ben Fidler • May 24, 2021 -
Sarah Silbiger via Getty Images
FDA seeking more consistency from cell, gene therapy developers, top official says
Several drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.
By Ned Pagliarulo • May 19, 2021 -
Erik S. Lesser via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Sean Gallup via Getty Images
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 -
Courtesy of BioNTech
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 7, 2021 -
Sarah Silbiger via Getty Images
FDA faces tough choice after panel backs speedy cancer drug approvals
The April meeting followed several immunotherapy withdrawals and led to multiple others, part of a push by the agency to review "dangling accelerated approvals."
By Ben Fidler , Ned Pagliarulo • April 30, 2021 -
Sean Gallup via Getty Images
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 -
Jacob Bell/BioPharma Dive
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 -
Courtesy of Eli Lilly
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 -
Sarah Silbiger via Getty Images
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 -
Jon Cherry via Getty Images
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 -
Warren Little via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Courtesy of Eli Lilly
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 -
Getty Images
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 -
Permission granted by Johnson & Johnson
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 -
FDA
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 -
Jacob Bell/BioPharma Dive
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 -
Permission granted by Gilead Sciences
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 -
Jacob Bell/BioPharma Dive
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 -
Jacob Bell/BioPharma Dive
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
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