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....

Enhertu of Daiichi Sankyo, AZ Gains HER2-Mutant Lung Cancer

FDA Approvals

With two significant FDA clearances in as many weeks, Enhertu from AstraZeneca and Daiichi Sankyo is blazing. On August 11th, the medication obtained rapid approval...

Pfizer Provides Facts To Back Up Prevnar 20 Authorization

FDA Approvals

Although Pfizer beat Merck to sell its next-generation pneumococcal vaccination, it lost a more important battle in June when the FDA said its competitor...

Pharma Criticises Drug Pricing Bill As Patient Groups Cheer

FDA Approvals

The pharmaceutical lobbying group's aura of invincibility has faded. The U.S. Senate recently passed a new bill, leaving the pharmaceutical sector licking its wounds...

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