• 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
  • Index insights
  • 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
  • Coronavirus
  • More reports can be found here

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

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

Regulatory
Regulatory RSS Feed RSS

HIF-PHI-delity? As FDA spins new tune in CKD anemia with GSK nod, others in class may hope to play along

Feb. 6, 2023
By Randy Osborne
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Read More

Regulatory actions for Feb. 6, 2023

Feb. 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lumiradx, SPR Therapeutics.
Read More

Regulatory actions for Feb. 6, 2023

Feb. 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Gracell, Maat, Octapharma, Orexo, Pharmala, Psycheceutical.
Read More

Orthogen granted IDE approval for medical technology for knee osteoarthritis

Feb. 3, 2023
By Bernard Banga
Orthogen AG received an investigational device exemption (IDE) from the U.S. FDA for its Orthogen technology device. This approval allows the company to start a pivotal trial on the device, used for treating patients with mild stage (II) to severe stage (IV) knee osteoarthritis. The trial will compare improvements in pain levels and function using standalone glucocorticoid injection, the current standard of care, against the Orthogen device.
Read More

MDMA’s Leahey says Medicare breakthrough device coverage still a work in progress

Feb. 3, 2023
By Mark McCarty
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
Read More

Regulatory actions for Feb. 3, 2023

Feb. 3, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Varian.
Read More

Regulatory actions for Feb. 3, 2023

Feb. 3, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Calliditas, GSK, Pfizer, Pharmather, Pliant, Y-mabs.
Read More
Kidney, pills, bottle

GSK’s daprodustat cleared as first FDA-approved oral HIF-PHI in CKD-related anemia

Feb. 2, 2023
By Jennifer Boggs
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
Read More
Close-up of eye with digital focus

Human factors engineering a requirement for software used with cameras for vital signs

Feb. 2, 2023
By Mark McCarty
The U.S. FDA recently posted the regulation for software used to derive vital signs from optical camera images thanks to a successful de novo petition by Oxford, U.K.-based Oxehealth Ltd., a regulation that carries the usual requirements for software verification and validation. However, the regulation also requires some human factors engineering (HFE) studies of the software interface, a requirement that may become more demanding to fulfill per a recent draft guidance on the subject.
Read More

FTC’s energy labeling rule draws fire from MITA over servicing provisions

Feb. 2, 2023
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has once again waded into the question of whether medical devices should be included in the agency’s right-to-repair discussion, most recently in an advanced notice of proposed rulemaking ostensibly titled for energy labeling. The Medical Imaging & Technology Alliance (MITA) pushed back on the proposal by pointing to the draft’s required disclosure of proprietary information about a medical device system, a provision MITA said might detract from patient safety.
Read More
Previous 1 2 … 338 339 340 341 342 343 344 345 346 … 1272 1273 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 11, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 8, 2025
  • Incurix describes new c-Myc inhibitors

    BioWorld Science
    Incurix Co. Ltd. has identified Myc proto-oncogene protein (c-Myc) inhibitors reported to be useful for the treatment of cancer.
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    With surface mimicry, molecular glues shed hairpin need

    BioWorld Science
    Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce...
  • 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
    • Index insights
    • 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
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe