Functional training leader TRX is advancing into the physical therapy & rehab sector via a three-pronged approach to injury recovery: PT-approved tools for clinic settings, PT-approved science-backed ...

Delaware and southeastern Pennsylvania business owner recognized by world's oldest and largest franchising association during Annual Convention in Las Vegas; Recognized for excellence in business, ...

Zydus will set its own prices for the generic product, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other business ...

Additionally, regulatory designations such as the Orphan Drug Designation (ODD) provide exclusivity periods, allowing companies to benefit from market monopolies for extended durations. This ...

Biodexa, which has already received U.S. FDA Orphan Drug designation for eRapa in FAP, plans to seek a similar designation in Europe. eRapa is a proprietary oral tablet formulation of rapamycin ...

Ianalumab, for the treatment of primary immune thrombocytopenia, was granted FDA orphan designation, according to a post on the ...

Biodexa, which has already received U.S. FDA Orphan Drug designation for eRapa in FAP, plans to seek a similar designation in Europe. eRapa is a proprietary oral tablet formulation of rapamycin ...

The research also notes that M&A deals have been the primary way in which big pharma companies secure these orphan drug designations, with very few rare disease drugs being developed in-house.

takes to rare disease treatments that have secured an orphan drug designation. That includes when orphan drugs go through the Single Technology Appraisal (STA) route; the route that most take.

U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, which is a new investigational drug for cannabis withdrawal syndrome. If approved ...

Ensoma Inc.’s lead program, EN-374, has been granted orphan drug and rare pediatric disease designations by the FDA for the ...