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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

In a separate development, Eisai has submitted a supplemental Biologics License Application (sBLA) to the US FDA for traditional approval of Leqembi. The post US FDA approves Eisai-Biogen’s antibody for Alzheimer’s appeared first on Pharmaceutical Technology.

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Takeda secures FDA approval for colon cancer drug

Bio Pharma Dive

The pharma paid $400 million to license the drug from Hutchmed earlier this year in an effort to bolster its oncology business.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer. The post AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer appeared first on Pharmaceutical Technology.

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Amicus Gets FDA Approval for Rare Muscle Disorder Treatment

BioSpace

Thursday’s approval comes after the FDA pushed back the target action dates for Amicus’ Biologics License Application in May, allowing the regulator more time to review the company’s submitted data.

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GSK pays $90M to gain access to Scynexis antifungal

Bio Pharma Dive

The licensing deal for the FDA-approved medicine, Brexafemme, includes milestone payments that could add up to $503 million.

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Cyfendus Anthrax Vaccine Wins FDA Approval

XTalks

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Additionally, 533 participants received at least one dose of the comparator-licensed anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed). Overall, 66.3

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MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

XTalks

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.