FDA: Page 23
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US curtails use of Vir, GSK's COVID-19 drug as omicron subvariant spreads
The drug, found to be ineffective against a coronavirus strain known as BA.2, is no longer authorized for use in 10 states and U.S. territories, a limitation that could be widened further.
By Ben Fidler • March 28, 2022 -
Sarah Silbiger via Getty Images
FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny
The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.
By Jonathan Gardner • March 25, 2022 -
Sarah Silbiger via Getty Images
FDA rejects Lilly and Innovent immunotherapy, sending signal to drugmakers
The regulator demanded the partners run another clinical trial to support approval of sintilimab, a decision that could have ripple effects for the development of cancer drugs in the U.S.
By Ben Fidler • March 24, 2022 -
Novartis wins FDA OK for radiopharmaceutical drug, cashing in on Endocyte deal
The approval of Pluvicto for prostate cancer is a notable step forward for the field of radiopharmaceutical therapy and validates the Swiss drugmaker's $2.1 billion buyout of Endocyte in 2018.
By Kristin Jensen • March 24, 2022 -
Sergio Flores via Getty Images
Moderna, with new data, to seek clearance for COVID-19 vaccine in young children
Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest.
By Ben Fidler • March 23, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers melanoma drug approved by FDA in immunotherapy advance
Opdualag is first approved drug that works by targeting a protein called LAG-3 and the third type of "checkpoint inhibitor" the agency has cleared for cancer.
By Ned Pagliarulo • March 21, 2022 -
Mario Tama via Getty Images
Pfizer, BioNTech seek FDA clearance of 4th shot amid worries over next COVID wave
The companies are forging ahead with plans to provide a second booster to people over 65, citing evidence, largely from observational studies in Israel, that diminishing protection may be restored with an additional shot.
By Ben Fidler • March 16, 2022 -
Ewa Krawczyk, National Cancer Institute
FDA clears AstraZeneca, Merck drug to treat some genetic breast cancers early
Lynparza is the first drug targeting BRCA mutations to be approved for use in early breast cancer, a decision that could lead to more genetic testing.
By Ben Fidler • March 14, 2022 -
Sarah Silbiger via Getty Images
FDA panel to review once-rejected Acadia drug for psychosis
The biotech company is making another attempt at expanding Nuplazid's use after an unexpected regulatory setback last year.
By Kristin Jensen • March 10, 2022 -
Permission granted by Bristol-Myers Squibb
In first, Bristol Myers wins FDA OK for Opdivo use before surgery in lung cancer
Opdivo's approval is another step in drugmaker efforts to establish immunotherapy drugs earlier in cancer treatment.
By Ben Fidler • March 7, 2022 -
Sarah Silbiger via Getty Images
FDA sets back Karyopharm's bid to broaden use of cancer drug
The biotech appeared poised to seek approval of its treatment, selinexor, in endometrial cancer. But regulators had a "differing" view of the data and requested another clinical trial.
By Kristin Jensen • March 2, 2022 -
Mario Tama via Getty Images
J&J, Legend cell therapy approved by FDA for multiple myeloma
The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma.
By Ned Pagliarulo • Updated March 1, 2022 -
Getty Images
FDA rejects Reata drug for rare kidney disease
While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.
By Jonathan Gardner • Feb. 28, 2022 -
Getty Images
Lilly, Boehringer diabetes pill wins expanded use in heart failure
The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.
By Jonathan Gardner • Feb. 25, 2022 -
Warren Little via Getty Images
Citing safety signal, GSK pauses some trials of new RSV vaccine
As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.
By Jonathan Gardner • Feb. 18, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets FDA decision date for earlier use of CAR-T therapy
The FDA will decide whether to approve Bristol Myers' Breyanzi for second-line lymphoma treatment by late June, two months after it's set to make a similar decision for Gilead's Yescarta.
By Ned Pagliarulo • Feb. 17, 2022 -
Win McNamee via Getty Images
Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency
Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.
By Jonathan Gardner • Updated Feb. 15, 2022 -
Courtesy of Pfizer
FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift
The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting that was scheduled for this week has been postponed as a result.
By Ben Fidler • Feb. 11, 2022 -
Sarah Silbiger via Getty Images
FDA sends signal with tough questions of Lilly at cancer drug meeting
The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.
By Jonathan Gardner • Feb. 10, 2022 -
Sarah Silbiger via Getty Images
Why the FDA is making a test case of a cancer drug from China
The FDA appears unlikely to approve an immunotherapy developed by Eli Lilly and China's Innovent Biologics, citing issues with their trial data. A rejection, however, could shut out lower-cost competition.
By Ben Fidler , Jonathan Gardner • Updated Feb. 10, 2022 -
Courtesy of Sanofi
Sanofi's Bioverativ deal begins to pay dividends with first new drug approval
The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.
By Jonathan Gardner • Feb. 7, 2022 -
Courtesy of Eli Lilly
Lilly slows FDA submission of Alzheimer's drug after Medicare decision
Executives for the pharma downplayed the impact of an accelerated approval for donanemab, pointing to Medicare's plans to restrict coverage of Alzheimer's drugs like it to only patients in clinical trials.
By Jonathan Gardner • Feb. 3, 2022 -
Getty Images
First generic of top-selling eye drug Restasis approved by FDA
At least nine generic drugmakers have tried to win approval of a lower-cost competitor to AbbVie's medicine, which has enjoyed market dominance for nearly two decades. Viatris is the first to succeed.
By Kristin Jensen • Feb. 3, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids
The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5 years of age continues.
By Kristin Jensen • Feb. 2, 2022 -
Roche wins FDA approval for rival to Regeneron's lucrative eye drug
The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants.
By Jonathan Gardner • Jan. 31, 2022
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