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BioWorld - Tuesday, February 3, 2026
Home » Topics » Regulatory

Regulatory
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Regulatory actions for Sept. 23, 2021

Sep. 23, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Algernon, Arcturus, Bluebird, Carisma, Cytodyn, Incyte, Inovio, Inventiva, Moberg, Pharmamar, Radius Health, Rhythm, Taysha Gene Therapies, Tryp.
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COVID-19 three-dose vaccine illustration

ACIP takes turn on COVID-19 booster, but FDA decision needed

Sep. 22, 2021
By Mari Serebrov and Lee Landenberger
Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
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Artificial intelligence and digital health icons

U.K. government eyes inventorship status in 10-year ‘global AI superpower’ plan

Sep. 22, 2021
By Mark McCarty
The U.K. government has doubled down on its overarching strategy for artificial intelligence (AI) with a 10-year plan to sustain the nation’s place in the global AI race. One of the key considerations in this plan is to revisit the criteria for status as an inventor, a clear nod to the dilemma presented by proponents of allowing the DABUS algorithm to be named as an inventor.
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Woman using Paige software on tablet

Paige receives FDA de novo authorization for AI product for prostate cancer detection

Sep. 22, 2021
By Annette Boyle
The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.
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U.K. flag on stethoscope

NICE says mitral valve-in-valve procedures not ready for routine utilization

Sep. 22, 2021
By Mark McCarty
The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.
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DNA in drug capsules

Bluebird files beta-thalassemia gene therapy, but questions mount over $1.8M price tag

Sep. 22, 2021
By Richard Staines
Bluebird Bio Inc. has completed a rolling BLA filing of beta-thalassemia gene therapy beti-cel in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe.
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Regulatory actions for Sept. 22, 2021

Sep. 22, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Ivwatch, Kleiner, Welldoc.
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Regulatory actions for Sept. 22, 2021

Sep. 22, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aft, Aim, Ampio, Genmab, Hyloris, Mayne, Seagen, Verrica.
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FDA approves Pfizer-Biontech COVID-19 vaccine booster, for some

Sep. 22, 2021
By Michael Fitzhugh

Incyte wins FDA approval for ruxolitinib cream in AD, with class-related boxed warnings

Sep. 21, 2021
By Michael Fitzhugh
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
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