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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Related Experiment Video

Updated: Jun 6, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

Rovadicitinib: First Approval.

Hannah A Blair1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|June 4, 2026
PubMed
Summary
This summary is machine-generated.

Rovadicitinib is a new JAK/ROCK inhibitor approved in China for myelofibrosis. This milestone marks the first approval for this JAK/ROCK inhibitor in treating PMF, PPV-MF, and PET-MF.

Related Experiment Videos

Last Updated: Jun 6, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

Area of Science:

  • Pharmacology
  • Oncology
  • Drug Development

Background:

  • Rovadicitinib is a novel small molecule inhibitor targeting Janus kinase (JAK) and Rho-associated coiled-coil-containing protein kinase (ROCK).
  • It is under development by Chia Tai Tianqing Pharmaceutical Group for myeloproliferative neoplasms and inflammatory conditions.
  • Targeted indications include primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (PET-MF), graft-versus-host disease (GVHD), and haemophagocytic lymphohistiocytosis (HLH).

Purpose of the Study:

  • To summarize the key developmental milestones of rovadicitinib.
  • To highlight the drug's journey leading to its first regulatory approval.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval processes.
  • Summary of key scientific and manufacturing achievements.

Main Results:

  • Rovadicitinib (Anxu®) received its first approval in China on February 25, 2026.
  • The approval is for the first-line treatment of adult patients with intermediate-2 or higher-risk PMF, PPV-MF, or PET-MF.

Conclusions:

  • The approval of rovadicitinib represents a significant advancement in the treatment of myelofibrosis.
  • This milestone underscores the successful development of a dual JAK/ROCK inhibitor for challenging hematological malignancies.