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Drug and Device Publications - FDAnews
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CDER’s 2021 Novel Drugs Report Shows Rising Trend of Approvals
网页2022年1月7日 · The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2021 — slightly fewer than 53 approved in 2020. Despite last year’s dip, CDER’s 2021 report on novel drug approvals released Thursday shows an increase in approvals over the past decade with some fluctuations from year to year. For example, approvals dipped from 39 in 2012 to 27 in 2013 and to a low of ...
FDAnews
网页2024年9月13日 · Regulatory Update — Week of Sept. 9, 2024. September 13, 2024. This week, the FDA published three medical device classifications — clinical chemistry and clinical toxicology devices, gastroenterology-urology devices and immunology and microbiology devices. The agency also published draft …
FDA Has Authorized 56 Breakthrough Devices So Far
网页2022年11月1日 · In the latest update on the FDA’s Breakthrough Devices program, the agency said that 56 medical devices that received breakthrough designations have gone on to gain marketing authorizations as of Sept. 30. A total of 728 devices have gained the designation as of Sept. 30, 2022 — the end of the fiscal year — including devices originally designated under the agency’s Expedited Access ...
FDA Starts Releasing Thousands of Pfizer COVID-19 Vaccine
网页2022年3月4日 · The FDA has begun releasing a court-mandated trove of documents pertaining to the agency’s review of Pfizer/BioNTech’s COVID-19 vaccine — which the agency authorized for emergency use in December 2020 before granting full approval in August 2021. The action stems from the FDA’s January court loss to a nonprofit group, Public Health and Medical Professionals for Transparency (PHMPT ...
FDA’s 2022 New Drug Approvals Feature Gene Therapies, Rare
网页2022年12月30日 · As the year comes to a close, we look at some of the FDA’s noteworthy new drug approvals, including two pricey gene therapies and other advancements for treatment of neurological conditions, such as Amyotrophic Lateral Sclerosis (ALS) and other rare diseases. Skysona Bluebird Bio received the FDA’s accelerated approval in September for its single-use gene therapy Skysona (elivaldogene ...
COVID-19 - FDAnews
网页2023年4月20日 · Eiger’s Peginterferon Lambda Cuts COVID-19 Hospitalizations in Half, Trial Shows. February 10, 2023. A single injection of Eiger Biopharmaceuticals’ peginterferon Lambda, an immune defense-stimulating protein, cut the rate of COVID-19 hospitalization by 51 percent compared to placebo, researchers reported in the New England Journal of Medicine.
Full Issue of Drug Industry Daily | 2022-09-21 | FDAnews
网页2022年9月22日 · That’s the contention of Deborah Livornese, director at the food and drug-focused law firm Hyman, Phelps & McNamara, who spoke during a recent WCG FDAnews webinar on FDA Commissioner Robert Califf’s agenda. The Overdose Prevention Framework, introduced Aug. 30, comes five years after the opioid crisis was declared a public health emergency ...
Omnibus Bill Passes, Increasing FDA Funding and Reforming
网页2022年12月27日 · Omnibus Bill Passes, Increasing FDA Funding and Reforming Accelerated Approvals. President Biden signed into law a $1.7 trillion omnibus spending package on Dec. 23, appropriating $3.5 billion in discretionary funding for the FDA through Sept. 30, 2023 — an increase of $226 million, or 6.5 percent, from what was enacted for the agency in 2022.
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