• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

FDA sign

FDA yanks Oncopeptides’ Pepaxto authorization for multiple myeloma

Dec. 7, 2022
By Jennifer Boggs
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Read More

Regulatory actions for Dec. 7, 2022

Dec. 7, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Moon Surgical, Shineco, Thermo Fisher, Ultromics.
Read More

Regulatory actions for Dec. 7, 2022

Dec. 7, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altrubio, Biocardia, Biogen, Curadev, Ocuphire, Sage, SQZ, Vistagen.
Read More
U.S. flag, stethoscope

IABP recall catches up with Getinge’s Datascope subsidiary, triggering shortages

Dec. 6, 2022
By Mark McCarty
Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing of units and parts is proceeding at the maximum pace allowed by supply chain volatility and recommended that hospitals facing shortages contact other nearby hospitals in the event of a lack of device availability.
Read More
Microscope with slide

US senators call for halt on gain-of-function research until oversight improves

Dec. 6, 2022
By Mari Serebrov
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
Read More

Regulatory actions for Dec. 6, 2022

Dec. 6, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Activ Surgical, Chronisense Medical, Imagen Technologies.
Read More

Regulatory actions for Dec. 6, 2022

Dec. 6, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Biogen, Hexaell, Ideaya, Idorsia, Pfizer, Protalix, Redhill, Syndax.
Read More
Real fluorescence microscopic view of human neuroblastoma cells

After a brutal adcom, Y-mabs gets an anticipated CRL

Dec. 5, 2022
By Lee Landenberger
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma.
Read More
Microscope with slide

US senators call for halt on gain-of-function research until oversight improves

Dec. 5, 2022
By Mari Serebrov
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
Read More

Regulatory actions for Dec. 5, 2022

Dec. 5, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apoqlar, Deep Blue Medical.
Read More
Previous 1 2 … 349 350 351 352 353 354 355 356 357 … 1259 1260 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 9, 2025.
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    BioWorld
    Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company...
  • The Nasdaq Stock Exchange headquarters in New York

    Omada, Caris arrivals continue med-tech IPO hot streak

    BioWorld MedTech
    Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe