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Novartis announced that it will acquire the UK-based ocular gene therapy company Gyroscope Therapeutics, giving Novartis a one-time gene therapy for geographic atrophy (GA), a leading cause of blindness. Read More
The FDA has put a clinical hold on Gilead Sciences’ injectable HIV drug lenacapavir because of the risk of glass particles from the vials getting into the medication. Read More
The FDA has declined to approve Takeda Pharamceutical’s new drug application for TAK-721, developed to treat a chronic inflammatory disease of the esophagus known as eosinophilic esophagitis. Read More
A group of 852 hospitals has sent Department of Health and Human Services (HHS) Secretary Xavier Becerra a letter pressing HHS to appeal a federal court ruling that drugmakers have the ability to restrict sales of medicine that’s handled by contract pharmacies as part of the 340B drug discount program. Read More
In its first authorization of a COVID-19 antiviral for home use, the FDA yesterday granted Emergency Use Authorization (EUA) to Pfizer’s COVID-19 oral antiviral Paxlovid for adults at high risk of progressing to severe disease, when alternative therapies approved or authorized by FDA are not accessible or clinically appropriate. Read More
Bluebird Bio pledged to work with the FDA to resolve the hold and said it expects to receive written questions from the agency on the program early next year. Read More
CEPI, the Coalition for Epidemic Preparedness Innovations, has joined with Korean biopharma firm SK Biopharma (SK) to develop a “variant-proof” vaccine that would protect against a large coronavirus subgenus that includes the SARS-CoV-2 virus that causes COVID-19. Read More