FDA: Page 24
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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 -
Getty Images
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 -
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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 -
Getty Images
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 -
Antonio Masiello via Getty Images
Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens
Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.
By Ben Fidler • Nov. 22, 2021 -
Permission granted by Biogen
Biogen seeking more information in investigation of Aduhelm patient's death
A new report from an RBC investment analyst suggested the Alzheimer's drug played a role, adding to questions around the treatment's safety.
By Ned Pagliarulo • Updated Nov. 19, 2021 -
Sarah Silbiger via Getty Images
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
A monthslong process of authorizing booster shots for vulnerable Americans culminated in the FDA's Nov. 19 decision to open eligibility for all adults, now all the more critical with omicron's spread.
By Ben Fidler • Updated Nov. 20, 2021 -
Win McNamee via Getty Images
Biden nominates Robert Califf to return as FDA head
If confirmed by Congress, the cardiologist would return to lead an agency facing weighty questions on COVID-19, a new user fee agreement and department staffing.
By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021 -
Mario Tama via Getty Images
Pfizer again asks FDA to authorize COVID-19 boosters for all adults
Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19.
By Jonathan Gardner • Nov. 9, 2021 -
Mario Tama via Getty Images
FDA extends review of J&J, Legend's cell therapy for multiple myeloma
The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.
By Jonathan Gardner , Ben Fidler • Nov. 2, 2021 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna faces delay in plans to bring coronavirus vaccine to US teenagers, young kids
The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S.
By Ben Fidler • Nov. 1, 2021
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