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
    • Ebola outbreak
    • Hantavirus
    • Trump administration impacts
    • Med-tech outlook 2026
    • 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, June 14, 2026
Home » Topics » North America » U.S.

U.S.
U.S. RSS Feed RSS

U.S. FDA headquarters

US FDA issues CRLs to Reata, Amryt and GC Pharma

Feb. 28, 2022
By Lee Landenberger

Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.


Read More
Omni system diagram

Sight Sciences launches campaign to increase stand-alone glaucoma surgeries

Feb. 28, 2022
By Annette Boyle
With a round of conference presentations and a new marketing program launched this week, Sight Sciences Inc. kicked off a focused effort to increase awareness of its Omni surgical system’s FDA clearance for glaucoma procedures performed independently of cataract surgery. The coordinated push aims to further boost revenues, which saw an estimated 65% increase compared to 2020 and 12% increase quarter-on-quarter, based on preliminary fourth quarter and fiscal year 2021 results.
Read More
Nugen device in use

Nugen sets its sights on US and Mexican type 1 diabetes markets

Feb. 25, 2022
By David Godkin
A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.
Read More
Illustration of DNA, magnifying glass

Oxford Biodynamics launches immune checkpoint inhibitor test in US

Feb. 25, 2022
By Catherine Longworth
Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment.
Read More
10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

FTC gives Boston Scientific a nod for updated divestiture plan

Feb. 24, 2022
By Mark McCarty
The U.S. Federal Trade Commission has signed off on an amendment to the divestiture plan for Boston Scientific Corp. (BSX), of Marlborough, Mass., related to the acquisition of British Technology Group plc (BTG).
Read More
Brain and encephalography

Neurosigma secures epilepsy breakthrough device designation for Monarch system

Feb. 24, 2022
By Catherine Longworth
Neurosigma Inc. has received FDA breakthrough device designation for its Monarch ETNS system to treat drug-resistant epilepsy (DRE). The neuromodulation therapy uses noninvasive external trigeminal nerve stimulation (ETNS) to treat neurological and neuropsychiatric indications. The technology is currently commercialized for pediatric ADHD treatment.
Read More
U.S.-China capsule

China-US licensing trending up in China’s quest for innovation

Feb. 24, 2022
By Mari Serebrov
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Read More
Concept illustration of the Livox system

Noninvasix breathes easier with breakthrough device designation

Feb. 23, 2022
By Annette Boyle
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware.
Read More
U.S. Securities and Exchange Commission

Former Pavmed employee hit with fine for insider trading

Feb. 23, 2022
By Mark McCarty
John-Michael Havrilla, formerly the director of investor relations at Pavmed, has agreed to pay $160,000 in civil penalties over allegations he used inside knowledge of an impending earnings report to help himself to $80,000 in ill-gained profits, a sure sign the SEC is not ignoring med-tech firms in its pursuit of insider trading charges.
Read More
Globe and currency symbols

Baxter agrees to $18M US SEC settlement over foreign exchange practices

Feb. 23, 2022
By Mari Serebrov
The U.S. SEC reported a settlement Feb. 23 with Baxter International Inc. and its former treasurer, Scott Bohaboy, and former assistant treasurer, Jeffrey Schaible, resolving charges involving years of improper intra-company foreign exchange transactions that resulted in the misstatement of Baxter’s net income.
Read More
Previous 1 2 … 476 477 478 479 480 481 482 483 484 … 612 613 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 12, 2026.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 9, 2026
  • Blood sample tubes after centrifuge

    Pre-disease plasma signature may help redefine lung cancer risk

    BioWorld
    Researchers have identified a 14-protein blood signature that can predict lung cancer risk as much as five years before diagnosis, and the findings could help...
  • Purple molecules

    Europe’s Alzecure, Orionis in $1B+ deals with Lilly, Novartis

    BioWorld
    Two companies with European ties signed billion-dollar deals with large pharma firms in the last two days to discover and develop molecular glue drugs, as well as...
  • Neck exam

    Ethyreal launches to treat the underlying cause of Graves’, TED

    BioWorld
    Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone...
  • 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