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 - Monday, May 25, 2026
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
Regulatory, BioWorld Asia RSS Feed RSS

Approved stamp
Biopharma approvals January 2026

China tops US in January drug approvals

Feb. 24, 2026
By Amanda Lanier
No Comments
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January.
Read More
Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 10, 2026
By Tamra Sami
No Comments
China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.
Read More
Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Read More

China NMPA approves Sciwind’s GLP-1 injection for diabetes

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
Read More
Pill with Japanese flag

Why many global drugs never reach Japan

Feb. 3, 2026
By Tamra Sami
No Comments
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
Read More

China accepts Telix/Grand Pharma NDA for TLX-591-CDx

Jan. 20, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
Read More
Cells and DNA helix

South Korea enacts world’s first regulation on synthetic biology

Jan. 13, 2026
By Marian (YoonJee) Chu
No Comments
South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
Read More

Hutchmed plans China NDA filing of sovleplenib in rare anemia

Jan. 13, 2026
By Marian (YoonJee) Chu
No Comments
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
Read More

Scinopharm wins US FDA approval of multiple sclerosis drug

Jan. 6, 2026
By Marian (YoonJee) Chu
No Comments
Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis.
Read More
Gold won currency symbol on black background

South Korea approves record budgets for health agencies in 2026

Jan. 6, 2026
By Marian (YoonJee) Chu
No Comments
South Korea’s National Assembly approved the largest budgets for its health ministries in 2026, including the Ministry of Health and Welfare, Ministry of Food and Drug Safety and Korea Disease Control and Prevention Agency.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 74 75 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 22, 2026.
  • Brain and DNA

    Sangamo presents primate data for prion suppressor ST-506

    BioWorld Science
    Sangamo Therapeutics Inc. discussed gene regulation approaches for neurodegenerative diseases when presenting findings on their clinical candidate ST-506 for the...
  • TREM2 agonists detailed in Pfizer patent

    BioWorld Science
    Pfizer Inc. has reported new triggering receptor expressed on myeloid cells 2 (TREM2) agonists potentially useful for the treatment of neurodegeneration.
  • Red dart and target against blue sky

    Unmasking the X: EPAC2 shifts the fragile X landscape

    BioWorld
    Researchers at UCLA have shown that divergent neuronal signaling in fragile X mice converges on EPAC2, a druggable target whose inhibition restores circuit...
  • Skin irritation on hands

    Recludix presents STAT1/3 inhibitors for dermatological diseases

    BioWorld Science
    Recludix Pharma Inc. recently presented data on their new STAT1/3 inhibitors REX-6553 and REX-6547 for treating dermatological inflammatory skin diseases.
  • 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