FDA
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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 -
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 • Jan. 5, 2022 -
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 -
Sarah Silbiger via 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 -
Phill Magakoe via 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 -
Dr_microbe via 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's new Alzheimer's drugBiogen 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 -
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 -
Sarah Silbiger via Getty Images
FDA clears Pfizer's coronavirus vaccine for children, moving US to next stage of rollout
The late October authorization opened up access to COVID-19 vaccines for millions of children between 5 and 11 years old in a major relief for parents after a difficult year.
By Shoshana Dubnow • Updated Nov. 1, 2021 -
Jacob Bell
FDA advisers support Pfizer's coronavirus vaccine for young children
Despite struggling with what some panelists called their toughest decision yet, the committee ultimately recommended COVID-19 vaccinations for 5- to 11-year-olds, which should pave the way for FDA authorization.
By Ned Pagliarulo • Oct. 26, 2021 -
Justin Sullivan via Getty Images
Deep DiveA play-by-play of the FDA's meeting on Pfizer's vaccine for kids
Experts on the agency's panel dug into questions on the vaccine's safety in younger children, as well as uncertainty over how widely it should be used. Catch up on the discussion here.
By Ben Fidler , Shoshana Dubnow , Jonathan Gardner • Updated Oct. 26, 2021 -
Courtesy of Roche
Roche's refillable eye implant becomes Eylea's latest threat
The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.
By Ben Fidler • Updated Oct. 25, 2021 -
Lisa Maree Williams via Getty Images
What to watch at the FDA's high-stakes meeting on COVID-19 vaccines for kids
Documents released by the FDA Friday indicate agency staff are supportive of Pfizer's data, setting up an advisory panel meeting Tuesday that could open the door for an authorization in young children.
By Ben Fidler , Ned Pagliarulo • Updated Oct. 24, 2021 -
Sergio Flores via Getty Images
FDA authorizes additional Moderna, J&J shots, broadening booster rollout
The agency also cleared booster shots to be used interchangeably, though it did not provide specific recommendations. A CDC advisory committee meeting Thursday might provide further guidance.
By Shoshana Dubnow • Updated Oct. 21, 2021
