FDA: Page 21
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Novartis breast cancer drug approved for ultra-rare condition
The FDA's decision was based on real-world study data that indicated Novartis' Piqray could treat a cluster of conditions known collectively as PROS.
By Ned Pagliarulo • April 6, 2022 -
Courtesy of Gilead Sciences
CAR-T treatment moves earlier as FDA widens approval of Gilead's Yescarta
Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.
By Ned Pagliarulo • April 4, 2022 -
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5 FDA decisions to watch in the second quarter
While a market downturn has weighed on the biotech industry, FDA approvals for drugs from Bristol Myers Squibb, Bluebird bio and Amylyx Pharmaceuticals could help the sector regain its footing.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • March 31, 2022 -
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FDA rejects Akebia drug, dealing another blow to anemia pills
The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.
By Jonathan Gardner • March 30, 2022 -
Sarah Silbiger via Getty Images
FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances
The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.
By Jacob Bell • Updated March 30, 2022 -
Jens Schlueter via Getty Images
FDA clears second COVID booster for older adults, immunocompromised
"This was a relatively straightforward decision," top FDA official Peter Marks told reporters. The agency plans to discuss booster use more broadly with an advisory panel next month.
By Ned Pagliarulo • Updated March 29, 2022 -
Sarah Silbiger via Getty Images
Deep Dive // ALS drug developmentHow a long shot ALS drug came before the FDA
A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision.
By Jacob Bell • March 28, 2022 -
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 -
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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 -
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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
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