FDA: Page 2

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

How 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

Explore the Trendline➔

The BioPharma Dive Outlook on 2022

After surging into 2021, biotech crashed at the end of last year amid negative clinical trial readouts, ebbing M&A and broader investor pullback. But the year ahead figures to be busy on several fronts and a slate of important studies could deliver good news. 

By BioPharma Dive staff

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

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

FDA, as expected, rejects Lilly and Innovent immunotherapy in 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 and cost of cancer immunotherapies 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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