Category Regulatory

Viridian Therapeutics Announces Inducement Grants Under Nasdaq Rule 5635(c)(4)

Viridian Therapeutics Announces Inducement Grants Under Nasdaq Rule 5635(c)(4)

Viridian Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies for serious and rare diseases, today announced that its Compensation Committee, consisting of a…

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Osivax

Osivax Secures Key Funding to Advance Next-Gen Influenza Vaccines

Osivax Secures Key Funding to Advance Next-Gen Influenza Vaccines Osivax, a biopharmaceutical company dedicated to developing next-generation vaccines that offer broad-spectrum protection against highly mutating respiratory viruses, has successfully secured strategic funding to accelerate the development of its influenza vaccine…

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Celltrion Secures EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra®

Celltrion Secures EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra®

Celltrion Secures EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® Celltrion has announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab). This approval marks a significant milestone for Celltrion, reinforcing…

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CHMP Recommends EU Approval of ENHERTU® for HER2 LowUltralow Metastatic Breast Cancer

CHMP Recommends EU Approval of ENHERTU® for HER2 Low/Ultralow Metastatic Breast Cancer

CHMP Recommends EU Approval of ENHERTU® for HER2 Low/Ultralow Metastatic Breast Cancer Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have achieved a significant milestone with the recommendation for approval of their drug ENHERTU® (trastuzumab deruxtecan) in the European Union…

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FDA Accepts sBLA for Opdivo® + Yervoy® in MSI-High/dMMR Cancers

FDA Accepts sBLA for Opdivo® + Yervoy® in MSI-High/dMMR Cancers U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy® for Patients with Unresectable or Metastatic Microsatellite Instability-High or Mismatch Repair Deficient Colorectal…

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