FDA Approvals

Beyfortus has received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency to treat lower respiratory tract...

BioMarin, CSL- Haemophilia Gene Treatments Win ICER Backing

FDA Approvals

Upcoming gene therapies may be the most economical option for people with haemophilia types A and B to address their illness, even with a...

Dupixent Charts A Win Before The FDA Prurigo Nodularis Order

FDA Approvals

Dupixent, the immunology favourite developed by Sanofi and Regeneron Pharmaceuticals, is still on the rise. It has received back-to-back approvals this year for the...

FDA Advisors Help Drug Amylyx For ALS, Altering Prior Stance

FDA Approvals

A group of Food and Drug Administration advisers has recently come out in favour of a carefully monitored ALS drug, increasing the likelihood that...

With FDA Approval, Revance With Daxxify Will Rival Botox

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...

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