FDA Approvals

Revance Therapeutics may soon run into an identity problem with a product that is so eagerly awaited that some people mistakenly call it by...

FDA Approves First Acid Sphingomyelinase Deficiency Cure

FDA Approvals

For intravenous infusion in paediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disorder that results in early death, the U.S....

Usual Pharma Compliance Issues Noted In FDA Warning Letters

FDA Approvals

According to a study of the reasons behind warning letters sent by the US Food and Drug Administration Center for Drug Evaluation and Research and Center for...

US Gives Lynparza Priority Review If Paired With Abiraterone

FDA Approvals

Priority consideration has been given to AstraZeneca's supplemental new drug application for Lynparza (olaparib) when used in conjunction with abiraterone, prednisone, or prednisolone to...

FDA Approves Zynteglo $2.8M Gene Treatment From Bluebird Bio

FDA Approvals

Gene therapy for blood disorders developed by Bluebird Bio has already left the nest in the US. Zynteglo, sometimes known as betibeglogene autotemcel (beti-cel), was...

Bayer Hires Lobbyists After Roe To Push Contraception Access

FDA Approvals

While a large portion of the biopharma industry prepares for a battle over medication prices, Bayer is getting ready for a different lobbying push...

Trodelvy Scores A Breast Cancer Survival Win For Gilead

FDA Approvals

Gilead staked money on Trodelvy providing a life-extension benefit when it failed to show promise in halting tumour development in HR-positive HER2-negative breast cancer....

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