All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, May 22, 2022
Home » Topics » North America » U.S.

U.S.
U.S. RSS Feed RSS

Bonesupport Cerament components

Bonesupport wins FDA nod for first antibiotic-eluting bone graft

May 19, 2022
By Meg Bryant
No Comments
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
Read More

ACIP recommends giving US kids a boost

May 19, 2022
By Mari Serebrov
No Comments
Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose.
Read More

US FDA churns out more guidances, updates

May 19, 2022
No Comments
Another spate of U.S. FDA guidances for prescription drug manufacturers includes updates for carton labeling, product-specific advice and recommendations on mitigating potential drug shortages.
Read More
UltraguideTFR

UltraguideTFR gets full market release to treat trigger finger

May 18, 2022
By David Godkin
No Comments
The full U.S. commercial launch of the UltraguideTFR is intended to crack a market of nearly nine million Americas suffering from a painful condition known as trigger finger, which is caused by the progressive restriction of tendon motion and the ability to bend and straighten the fingers.
Read More
05-18-Aptima-CMV-Box.png

FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
No Comments
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
Read More

Patient assistance programs will live to see another year

May 18, 2022
By Mari Serebrov
No Comments
A U.S. district court slapped down a controversial Department of Health and Human Services rule that threatened the future of biopharma companies’ patient assistance programs, which are intended to help patients cover their out-of-pocket costs for pricy drugs.
Read More

Senate user fee bill adds VALID Act despite omission in House user fee bill

May 17, 2022
By Mark McCarty
No Comments
The Senate Health, Education, Labor and Pensions (HELP) Committee has posted its version of U.S. FDA user fee legislation, a bill that echoes many of the primary features of the version already at play in the House of Representatives. One critical difference is that the Senate bill includes legislation that would enable the FDA to regulate lab-developed tests (LDTs), the so-called Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the omission of which from the House bill ruffled a few feathers. The American Clinical Laboratory Association (ACLA) responded to the Senate bill with a May 17 statement applauding the inclusion of the VALID Act in the Senate user fee bill.
Read More

US FDA lowers age for COVID-19 boosters to 5 years old

May 17, 2022
By Mari Serebrov
No Comments
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
Read More

US FDA updates drug OOS guidance

May 17, 2022
No Comments
Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”
Read More
Medtronic plc’s Onyx Frontier drug-eluting stent

FDA greenlights Medtronic Onyx Frontier stent

May 16, 2022
By Annette Boyle
No Comments
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 150 151 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 20, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech's briefs for May 20.
  • China U.S. deal

    Merck acquires global rights to cancer drug from Kelun in $1.4B deal

    BioWorld
    In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for...
  • Illustration of cancer cells and immunotherapy treatment

    Former Genentech execs launch new immunotherapy biotech LTZ Therapeutics

    BioWorld
    After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose...
  • US FDA rejects UCB psoriasis drug Bimzelx, citing facility inspection issues

    BioWorld
    UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • 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
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing