BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Hospital at home tech2

OIG sees holes in Medicare oversight of remote patient monitoring

Sep. 27, 2024
By Mark McCarty
In some ways, remote patient monitoring (RPM) came of age during the COVID-19 pandemic, but payers still worry about the potential for fraud and abuse. A recent report from the U.S. Office of Inspector General supported concerns about fraud and abuse with RPM, a problem CMS will have to address to constrain unnecessary and potentially illicit spending.
Read More
Innosys bone putty

Innosys launches Velofuse bone graft products

Sep. 27, 2024
By Marian (YoonJee) Chu
Korean med-tech firm Innosys Co. Ltd. recently launched two new injectable spine bone graft substitute products – Velofuse Gel and Velofuse Putty – and announced a name change to CG Medtech Co. Ltd., effective Nov. 4, 2024.
Read More
Cobenfy

US FDA clears Cobenfy, first new schizophrenia drug in decades

Sep. 27, 2024
By Nuala Moran
The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies. Bristol Myers Squibb Co., which acquired Cobenfy developer Karuna Therapeutics Inc. for $14 billion in a deal that closed in March 2024, said the drug will be available in the U.S. from late October.
Read More
U.S. Capitol building

US Congress avoids government shutdown, extends voucher program

Sep. 26, 2024
By Mari Serebrov
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20.
Read More
U.S. Capitol building

US Congress avoids government shutdown, extends voucher program

Sep. 26, 2024
By Mari Serebrov
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.
Read More
Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.

ODAC expresses itself on PD-L1, checkpoint inhibitors

Sep. 26, 2024
By Randy Osborne
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
Read More

Pfizer pulls sickle cell drug after deaths and health complications

Sep. 26, 2024
By Lee Landenberger
The risk and benefit of Pfizer Inc.’s oral sickle cell disease drug Oxbryta (voxelotor) has flipped, prompted by what the company called new clinical data indicating “an imbalance in vaso-occlusive crises and fatal events” that need more study. Based on an EMA recommendation, Pfizer said it is voluntarily recalling all lots of Oxbryta from wherever it’s approved worldwide. Pfizer also is shuttering its Oxbryta clinical studies and expanded access programs.
Read More
Brain illustrated with pills

Karxt for schizophrenia awaits US FDA decision; inventor opines

Sep. 26, 2024
By Nuala Moran
Nine years on from securing $3.84 million for a phase I clinical trial to test the formulation, with results showing it overcame side effects that had confounded its forerunner, the schizophrenia treatment Karxt met its PDUFA date Sept. 26 with no decision by midday. If approved, the fixed combination of xanomeline-trospium will be the first in a new drug class, and as a dual M1/M4 muscarinic agonist, the first new therapy to act via a novel mechanism for the serious psychiatric disorder in over 50 years.
Read More
Transdermal patch on arm

China approves Sino Biopharm’s patch for Alzheimer’s disease

Sep. 26, 2024
By Tamra Sami
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
Read More

New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Sep. 26, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
Read More
Previous 1 2 … 163 164 165 166 167 168 169 170 171 … 1340 1341 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Feb. 6, 2025.
  • Brain illustration

    MJFF grant supports Bexorg’s translational biomarker work

    BioWorld Science
    Bexorg Inc. has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) through the Targets to Therapies initiative to...
  • Brain and DNA

    REST emerges as biomarker in ALS, knockdown improves ALS symptoms

    BioWorld Science
    About 10% of amyotrophic lateral sclerosis (ALS) cases result from inherited genetic mutations, with about 20% of them attributed to mutations in the gene...
  • Brain illustrated with pills

    Serotonin receptor modulators for the treatment of OUD

    BioWorld Science
    Opioid use disorder (OUD) causes high morbidity and mortality rates, with fentanyl driving unprecedented overdose rates. Researchers from the University of...
  • Liver anatomy illustration

    KLF15 shows potential as marker, target for cholangiocarcinoma

    BioWorld Science
    Researchers at the Biodonostia Health Research Institute reported on the role of KLF15 in cholangiocarcinogenesis and its potential as a therapeutic target in...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing