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FDA Breakthrough Therapy Designation Granted For Promising Rectal Cancer Drug
T he US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to a cancer drug called dostarlimab ...
Cure Today2d
FDA Grants Jemperli Breakthrough Therapy Designation in dMMR/MSI-H Rectal Cancer
Jemperli received breakthrough therapy designation by the FDA for locally advanced mismatch repair deficient/microsatellite ...
pharmaphorum5d
FDA ‘breakthrough’ status – a new tool for building oncology brands?
The FDA's new Breakthrough ... been for cancer drugs. And in terms of oncology branding, it makes perfect sense. Breakthrough status is a far better branding strategy than orphan disease ...
FierceBiotech4d
Omeros antibody improves overall survival by 68% in rare condition, new analysis finds
Omeros is putting up its monoclonal antibody up for FDA approval—again. | Omeros is putting up its monoclonal antibody up for ...
pharmaphorum3d
Following FDA encouragement, Faron’s orphan drug gets UK special designation
The PIM designation is similar to the FDA'S Breakthrough ... is a severe orphan disease with a reported mortality rate of around 30–45%, for which there is currently no approved drug treatment.
ophthalmologytimes6d
Atsena Therapeutics completes dosing in Part A of phase I/II clinical trial evaluating ATSN-201 to treat X-linked retinoschisis
In the LIGHTHOUSE study, Atsena Therapeutics is evaluating ATSN-201 gene therapy for X-linked retinoschisis, leveraging ...
Le Lézard5d
Holoclara Selects Eosinophilic Esophagitis as its Lead Indication for HC002, a First-in-Class Worm-Derived Therapy
Holoclara, a biotechnology company pioneering the development of worm-derived therapies for allergic and autoimmune disorders, today announced the selection of eosinophilic esophagitis (EoE) as its ...
JD Supra5d
FDA Nominee Makary on the Orphan Drug Act
President-elect Trump’s nominee for commissioner of Food and Drugs, Martin A. Makary, MD, MPH, argued in 2016 that Congress should reform the ...
Seeking Alpha on MSN4d
Aquestive receives FDA Orphan Drug Exclusivity for Libervant
Aquestive Therapeutics (NASDAQ:AQST) has received FDA Orphan Drug Exclusivity for its drug Libervant Buccal Film in the ...
Yahoo Finance6d
FDA Approves Orphan-Drug Designation for Jaguar Health’s Crofelemer for Treatment of Diarrhea in Cholera
Jaguar Health (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD ...