FDA: Page 19
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Monty Rakusen via Getty Images
Sponsored by CorEvitasUnderstanding real-world data in the real world
Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond.
May 2, 2022 -
Sergio Flores via Getty Images
Moderna seeks FDA clearance for COVID-19 vaccine in young children
The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.
By Kristin Jensen • April 28, 2022 -
Sarah Silbiger via Getty Images
FDA panel supports agency push to raise approval bar for certain cancer drugs
Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.
By Jonathan Gardner • April 22, 2022 -
Sarah Silbiger via Getty Images
GSK to test FDA's tough stance on anemia pills
Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.
By Ben Fidler • April 19, 2022 -
Jacob Bell/BioPharma Dive
Troubling data leads a biotech to pull its prized drug from market and FDA review
Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.
By Jacob Bell • April 18, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds
A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.
By Kristin Jensen • April 14, 2022 -
Justin Sullivan via Getty Images
FDA clears Gilead to restart some studies of top cancer drug
The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.
By Ben Fidler • April 12, 2022 -
Sarah Silbiger via Getty Images
'Where's the patient?': Experts question FDA's device recall guidance
While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.
By Ricky Zipp • April 6, 2022 -
Sergio Flores via Getty Images
FDA advisers grapple with how to update COVID-19 vaccines
About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.
By Ned Pagliarulo • Updated April 7, 2022 -
Sarah Silbiger via Getty Images
FDA halts Vir, GSK antibody use in response to COVID subvariant's spread
The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.
By Kristin Jensen • April 6, 2022 -
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 -
Sarah Silbiger via Getty Images
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 -
ismagilov via Getty Images
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 development
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 -
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
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