- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
OS Therapies expands global regulatory submission plans for cancer immunotherapy
What happened
OS Therapies, Inc. announced that the World Health Organization approved the proprietary name 'Herlystic' and the nonproprietary name daznelimgene lisbac for its drug OST-HER2. The Company plans to initiate international regulatory submissions, starting with the UK, and subsequently expanding to the U.S. Food & Drug Administration, the European Medicines Agency, and the Australian Therapeutic Goods Administration.
From finanznachrichten.de
Why it matters
The approval of the drug's name by the World Health Organization positions the Company to seek early market access worldwide. The Company has accepted the role of coordinating international submissions under Project Orbis, an initiative of the FDA's Oncology Center of Excellence.
The Company is currently conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
From finanznachrichten.de
Who's involved
- CompanyWorld leader in gene-edited, Listeria-based cancer immunotherapies
- FDARegulatory agency whose approvals are crucial for the Company's market viability
- European Medicines AgencyRegulatory body the Company plans to submit to for European market access
- projectCollaborative enterprise under which the Company will coordinate international submissions
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- FDASpeculative
The FDA might see increased demand for regulatory review capacity as the Company initiates submissions for early market access.
- European Medicines AgencySpeculative
The European Medicines Agency could see increased demand for regulatory review capacity as the Company initiates submissions for early market access.
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
- BioPorto is seeking regulatory pathways and activating its first clinical site in collaboration with Massachusetts General Hospital.
- Veradermics, Incorporated is seeking federal regulatory approval from the FDA for its drug candidates.
- Oversight failures and regulatory inertia in the U.S. drug approval process were exposed on August 3rd, involving the FDA and Merck.
The entities involved
- FDA
-
European Medicines Agency
highest regulatory authority on medicines in the European Union
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Company
Direct Mail Division of FSSI
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