• 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

Red wooden approved stamp

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Jan. 28, 2025
By Tamra Sami
Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
Read More
Gavel and vials

FCA cases reach new high in 2024, but value of recoveries no outlier

Jan. 28, 2025
By Mark McCarty
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts.
Read More

Biohaven’s pre-acquisition deeds lead to $60M payout for Pfizer

Jan. 27, 2025
By Mari Serebrov
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
Read More
MHRA logo

UK’s postmarket monitoring mandates to take force in June

Jan. 27, 2025
By Mark McCarty
The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.
Read More
US flag, gavel, book

Bard agrees to pay $17M to settle FCA allegations

Jan. 27, 2025
By Mark McCarty
Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.
Read More
Colorized transmission electron micrograph of SARS-CoV-2.
Immune

Ocugen’s OCU-500 inhaled mucosal vaccine for COVID-19 gains IND clearance

Jan. 27, 2025
Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.
Read More
Gavel and pill blister packs

US Claims Court rules Vanda’s trade secrets not so secret

Jan. 24, 2025
By Mari Serebrov
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
Read More
Abbott sign

PFA update: Abbott to launch in EU, J&J hold indefinite

Jan. 24, 2025
By Annette Boyle
A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.
Read More
Laptop displaying FDA logo

FDA dishes out five device warnings to begin 2025

Jan. 24, 2025
By Mark McCarty
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
Read More
Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Jan. 24, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
Read More
Previous 1 2 … 43 44 45 46 47 48 49 50 51 … 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.
  • 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...
  • 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...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 3, 2025
  • 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