• 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

Regulatory actions for June 22, 2023

June 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eyenuk, Haemonetics, VVT Medical.
Read More
U.S. Supreme Court

US Supreme Court reaffirms government’s authority to dismiss whistleblower FCA cases

June 22, 2023
By Mark McCarty
The question of when U.S. federal attorneys can dismiss a whistleblower suit filed under the False Claims Act (FCA) has roiled the courts for several years, but the Supreme Court has laid many of those questions to rest in an 8-1 ruling which said that the government can dismiss a whistleblower FCA case only after federal attorneys have intervened.
Read More

PhRMA suit: IRA negotiations also a ‘taking’ from patients, providers

June 21, 2023
By Mari Serebrov
The floodgates have opened for challenges to the new U.S. drug price negotiation process laid out in the Inflation Reduction Act (IRA) that was narrowly passed last year.
Read More

China greenlights Salubris’ HIF-PH inhibitor for anemia

June 21, 2023
By Doris Yu
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease (CKD) that are not on dialysis.
Read More

SK Bioscience strives for ‘equal access’ to Korean COVID-19 vaccine with WHO approval

June 21, 2023
By Marian (YoonJee) Chu
The World Health Organization (WHO) recently gave an emergency use listing (EUL) for SK Bioscience Ltd.’s COVID-19 vaccine called Skycovione, a self-assembled nanoparticle vaccine that targets the SARS-CoV-2 spike protein.
Read More
Eye and financial charts

No studies, no data, no approval: Aldeyra gets a CRL

June 21, 2023
By Lee Landenberger
In its newly issued complete response letter (CRL) to Aldeyra Therapeutics Inc., the U.S. FDA said there’s just not enough evidence of efficacy right now to approve ADX-2191, an injectable vitreous-compatible formulation of methotrexate to treat primary vitreoretinal lymphoma (PVRL).
Read More

Vyvgart Hytrulo wins U.S. FDA approval for generalized myasthenia gravis

June 21, 2023
By Karen Carey
Following a three-month delay, the U.S. FDA approved under priority review a subcutaneous formulation of Argenx SE’s efgartigimod, offering patients a much more convenient way to treat generalized myasthenia gravis (gMG).
Read More

Regulatory actions for June 21, 2023

June 21, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aardvark, Advantage, Agepha, Akebia, Aldeyra, Amarin, Amgen, Arcellx, Argenx, Aridis, ARS, Biologix, Boehringer Ingelheim, Geron, Pfizer, Precigen, Replay, Sonnet.
Read More

Regulatory actions for June 21, 2023

June 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anumana, Lumira, Mediso, Qiagen.
Read More

MHRA adopts device nomenclature system into device registration database

June 21, 2023
By Mark McCarty
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents.
Read More
Previous 1 2 … 279 280 281 282 283 284 285 286 287 … 1268 1269 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 2, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 2, 2025.
  • Molecule illustration

    Unnatural Products joins Argenx in a $1.5B macrocyclic deal

    BioWorld
    Unnatural Products Inc. notched another collaboration by signing on with Argenx SE in a multitarget research collaboration. Unnatural Products, which is getting...
  • Illustration of the β2-adrenergic receptor

    Exercise-mimicking compound offers alternative to GLP-1 therapies

    BioWorld
    An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR)...
  • CMS logo and website

    CMS eyes competitive bidding for CGMs, insulin pumps

    BioWorld MedTech
    The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous...
  • 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