• 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

Mirati’s Krazati to take on first-mover Lumakras after FDA nod in KRAS-mutated NSCLC

Dec. 14, 2022
By Jennifer Boggs
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.
Read More

Regulatory actions for Dec. 14, 2022

Dec. 14, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Quantumdx.
Read More

Regulatory actions for Dec. 14, 2022

Dec. 14, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1st, AB, Boehringer, Carina, Cytokinetics, Erasca, Eyenovia, Mersana, Mirati, Mirum, Myrtelle, NMD, Panbela, Pharmajet, Remegen, Virpax.
Read More
Laptop displaying FDA logo
2022 FDLI Enforcement Conference

Industry sees potential for undue risk in FDA’s remote regulatory audit program

Dec. 13, 2022
By Mark McCarty
The U.S. FDA’s use of remote regulatory assessments (RRAs) during the pandemic may have been inevitable, but a proposed continuation of the program in the endemic phase of the SARS-CoV-2 contagion hasn’t necessarily won over device manufacturers.
Read More
Heart scientific overlay

Cytokinetics gets applause but no golden ticket

Dec. 13, 2022
By Mari Serebrov
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
Read More
Red wooden approved stamp

Shionogi scores emergency approval for Japan’s first domestic COVID-19 oral antiviral

Dec. 13, 2022
By Tamra Sami
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
Read More

Regulatory actions for Dec. 13, 2022

Dec. 13, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Axonics, Eyenovia, Mediwound, Qiagen.
Read More
COVID-19 vaccine and syringe with flag of China

China grants emergency use of new vaccines as it eases COVID-19 policy

Dec. 13, 2022
By Doris Yu
China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.
Read More

Regulatory actions for Dec. 13, 2022

Dec. 13, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainstorm, Evergreen, Galera, Ideaya, Janssen, Medivir, Pfizer, Recce, Sobi, Vertex.
Read More
Blue heart and data grid

Cytokinetics hoping for good adcom review of heart failure drug

Dec. 12, 2022
By Mari Serebrov
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
Read More
Previous 1 2 … 348 349 350 351 352 353 354 355 356 … 1260 1261 Next

Popular Stories

  • Today's news in brief

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

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

    BioWorld Asia
    BioWorld Asia briefs for June 10, 2025
  • Neuronata-R

    Corestemchemon preps US BLA filing for stem cell ALS therapy

    BioWorld Asia
    Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company...
  • Enflonsia

    Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

    BioWorld
    With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and...
  • 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