In the United States, Breakthrough Therapy designation is granted by the U.S. Food and Drug Administration (FDA) to expedite drug development and review. This designation is granted to therapies that…
In a recent news release, commercial-stage biopharmaceutical company HUTCHMED shared that its investigational therapy HMPL-523 had received Breakthrough Therapy designation from the National Medical Products Administration (NMPA) in China. HMPL-523…
In a news release from July 21, 2021, biotechnology company Genentech shared that its therapy Venclexta (venetoclax), in conjunction with azacitidine, received Breakthrough Therapy designation from the FDA. Overall, the…
According to the Cancer Network, orelabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was recently granted Breakthrough Therapy designation within the United States. While the treatment is also indicated for patients…
Breakthrough Therapy designation is granted by the FDA as a way to accelerate drug development and review. In particular, the designation is granted to drugs or biologics for serious conditions,…
On July 14, 2021, biopharmaceutical company Alkeus Pharmaceuticals, Inc. ("Alkeus") shared via press release that its therapy ALK-001 (C20-D3-vitamin A) received Breakthrough Therapy designation from the FDA for the treatment…
The FDA has a series of designations it grants to drugs or biologics intending to treat rare, serious, or life-threatening conditions. One of these is Breakthrough Therapy designation. According to…
The FDA has recently granted the Breakthrough Therapy designation to FARXIGA, a chronic kidney disease treatment created by AstraZeneca. This designation will allow for a quicker development, which will hopefully…
There are few things more frightening and horrifying for a new parent than being told that their child has a lifelong medical disorder. Perhaps the only words that could make…
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