FDA: Page 22
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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 -
Courtesy of Regeneron Pharmaceuticals
Regeneron, Sanofi are latest to withdraw a cancer drug application
The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.
By Jonathan Gardner • Jan. 28, 2022 -
Sarah Silbiger via Getty Images
A biotech wins the first FDA drug approval in a rare type of eye cancer
U.K.-based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S. so far.
By Jonathan Gardner • Jan. 26, 2022 -
Sarah Silbiger via Getty Images
Incyte withdraws cancer drug from FDA review after discussions with regulator
The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals.
By Kristin Jensen • Jan. 26, 2022 -
Justin Sullivan via Getty Images
Gilead's oncology plans take a hit as FDA stops tests of key cancer drug
U.S. regulators halted several studies of a drug Gilead paid almost $5 billion to acquire in 2020 after researchers observed an "apparent imbalance" of serious adverse reactions.
By Ben Fidler • Jan. 26, 2022 -
Permission granted by Gilead Sciences
US turns to Gilead's COVID-19 drug to help counter omicron
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
By Ben Fidler • Jan. 24, 2022 -
FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi
AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.
By Jacob Bell • Jan. 18, 2022 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 questions facing the FDA in 2022
If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.
By Jonathan Gardner • Jan. 11, 2022 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the first quarter
The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug, as well as mark the start of a price battle in oncology.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • Updated March 1, 2022 -
Permission granted by Novartis
Novartis wins FDA approval for new heart drug, but faces uphill sales battle
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
By Jonathan Gardner • Dec. 22, 2021 -
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FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push
The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.
By Ned Pagliarulo • Dec. 20, 2021 -
Getty Images
J&J's coronavirus vaccine faces new US limits
Days after the FDA strengthened safety warnings for J&J's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred."
By Jonathan Gardner • Updated Dec. 17, 2021 -
Sarah Silbiger via Getty Images
FDA panel turns down Reata kidney disease drug in unanimous vote
The company said it will keep working with the FDA ahead of a Feb. 25 decision date, but the committee's verdict greatly diminishes the drug's chances of an approval.
By Kristin Jensen • Dec. 9, 2021 -
Getty Images: Edited by BioPharma Dive
Intercept, awaiting needed trial data, pulls its NASH drug application in Europe
The biotech has lost much of its market value amid delays and regulatory questions for obeticholic acid. But the failures of other drugmakers still leave the company with a chance to rebound.
By Ben Fidler • Dec. 9, 2021 -
Courtesy of AstraZeneca
AstraZeneca antibody cleared by FDA for preventive use against COVID-19
Evusheld, a combination of two antibodies, is meant to be long-acting, proving protective against disease through six months in clinical testing.
By Ned Pagliarulo • Dec. 8, 2021 -
Courtesy of Eli Lilly
Lilly drug becomes first COVID antibody cleared for use in young children
The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.
By Jonathan Gardner • Dec. 6, 2021 -
Courtesy of Merck & Co.
FDA panel, after debate, narrowly backs Merck COVID pill
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
By Jonathan Gardner • Updated Nov. 30, 2021 -
Courtesy of Merck & Co.
New Merck study results raise questions about its COVID pill
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
By Ben Fidler • Nov. 26, 2021 -
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Takeda wins US approval for new CMV treatment
The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.
By Kristin Jensen • Nov. 24, 2021
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