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Home » Topics » Regulatory

Regulatory
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Neurology/psychiatric

Solid Biosciences gains IND clearance for Friedreich’s ataxia gene therapy

Jan. 8, 2025
Solid Biosciences Inc. has gained IND clearance from the FDA for SGT-212 for the treatment of Friedreich’s ataxia (FA).
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Heart illustration
Cardiovascular

Cyclarity’s UDP-003 to enter clinic for acute coronary syndrome

Jan. 8, 2025

Cyclarity Therapeutics Inc. has obtained regulatory approval to begin a first-in-human trial of UDP-003. 


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Immuno-oncology

SYS-6045 cleared for clinic in China for advanced solid tumors

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
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Lungs
Respiratory

SYH-2059 to enter trials in China for interstitial lung disease

Jan. 8, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of SYH-2059 tablets for interstitial lung disease, including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
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US FDA weighs in on timing of confirmatory trials

Jan. 7, 2025
By Mari Serebrov
What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.
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Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 7, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
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Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 7, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
Read More
Glass vial production line

Taiwan’s Tanvex receives second CRL for Herceptin biosimilar

Jan. 7, 2025
By Tamra Sami
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
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Athira to pay $4M to resolve research misconduct allegations

Jan. 7, 2025
By Mari Serebrov
Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. has agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 7, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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