BioLineRx Ltd.
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Latest From BioLineRx Ltd.
A Standard September Ahead Thanks To Light US FDA User Fee Calendar With Few Expedited Reviews
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
10 Approvals To Look Out For In Q3 2023
The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.
40+ Candidates Give US FDA Plenty Of Latitude While Growing 2023 Novel Approval Count From 2022
User fee goal dates in the second half of 2023 suggest cancer and breakthrough therapy approvals should recover from first-half dips and a resumption of inspections in China could revive COVID-delayed products.
Gamida Cell Bounces Back With Omisirge US Approval
The Israeli firm Gamida Cell’s lead candidate has obtained a US approval as a new donor source for allogeneic stem cell transplant with the chips in place for independent commercialization despite its recent financial troubles.
Company Information
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Pharmaceuticals
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
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- Agalimmune Limited
- Agalimmune Ltd.
- Agalimmune Inc.
- iPharma
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