In a groundbreaking move, the US Food and Drug Administration (FDA) moved to rescind marketing exclusivity for an orphan drug product manufactured by OctaPharma used for the treatment of von ...

The House Energy & Commerce Committee on Wednesday considered four bills, supported by members on both sides of the aisle, that focus on companies gaming the orphan drug exclusivity process, allowing ...

Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 ...

More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. By the ...

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1] In brief, the Catalyst decision ...

Federal drug regulators say they’ll stand by their existing system of awarding orphan drug exclusivity, restoring the approach in place prior to a recent legal feud. The announcement promises to ...

If the FDA has its way, other drugmakers won't benefit from a recent federal court decision ordering the agency to grant Depomed Inc. orphan drug exclusivity for its postherpetic neuralgia (PHN) drug ...

(RTTNews) - Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company focused on delivering innovative medicines, announced that the FDA has granted Orphan Drug Exclusivity to Libervant (diazepam) ...

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative ...

- YUVIWEL was granted orphan drug exclusivity by U.S. FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses - YUVIWEL is now commercially ...