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RSS FeedPosted by Michael Wonder on 31 Dec 2019
Savara granted breakthrough therapy designation for Molgradex for the treatment of auto-immune pulmonary alveolar proteinosis
30 December 2019 - Savara today announced that the U.S. FDA has granted breakthrough therapy designation for Molgradex, an inhaled ...
Posted by Michael Wonder on 18 Dec 2019
Seattle Genetics announces U.S. FDA grants breakthrough therapy designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer
18 December 2019 - New drug application submission to U.S. FDA expected by first quarter of 2020. ...
Posted by Michael Wonder on 18 Dec 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation
16 December 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) for ...
Posted by Michael Wonder on 09 Dec 2019
Galderma investigational therapy nemolizumab granted FDA breakthrough therapy designation for the treatment of patients suffering from prurigo nodularis
9 December 2019 - Galderma today announced that the U.S. FDA has granted breakthrough therapy Designation to the investigational therapy ...
Posted by Michael Wonder on 07 Dec 2019
Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma
6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...
Posted by Michael Wonder on 04 Dec 2019
ImmunityBio granted FDA breakthrough therapy designation for N-803 IL-15 superagonist in non-muscle invasive bladder cancer
4 December 2019 - Results of Phase 1 and 2 studies in BCG unresponsive non-muscle invasive bladder cancer in high risk ...
Posted by Michael Wonder on 04 Dec 2019
Bristol-Myers Squibb announces U.S. FDA breakthrough therapy designation for Orencia (abatacept) to help prevent acute graft-versus-host disease, a potentially life-threatening complication after stem cell transplant
4 December 2019 - Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for Orencia (abatacept) ...
Posted by Michael Wonder on 22 Nov 2019
FDA grants breakthrough therapy designation to Usona Institute's psilocybin program for major depressive disorder
22 November 2019 - Usona Institute has received breakthrough therapy designation from the US FDA for psilocybin in the treatment ...
Posted by Michael Wonder on 21 Nov 2019
Kiniksa announces breakthrough therapy designation for rilonacept for the treatment of recurrent pericarditis
20 November 2019 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation for rilonacept for the ...
Posted by Michael Wonder on 19 Nov 2019
Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C
19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...
Posted by Michael Wonder on 12 Nov 2019
X4 Pharmaceuticals receives breakthrough therapy designation from the FDA for mavorixafor for the treatment of WHIM syndrome
12 November 2019 - X4 Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for mavorixafor (X4P-001) ...
Posted by Michael Wonder on 11 Nov 2019
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for patients with previously treated advanced hepatocellular carcinoma
11 November 2019 - The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication. ...
Posted by Michael Wonder on 11 Nov 2019
F2G receives US FDA breakthrough therapy designation for Olorofim
11 November 2019 - First anti-fungal agent to receive breakthrough therapy designation. ...
Posted by Michael Wonder on 28 Oct 2019
Mirum Pharmaceuticals announces breakthrough therapy designation for maralixibat for the treatment of pruritus associated with Alagille syndrome
28 October 2019 - Mirum Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for maralixibat for the ...
Posted by Michael Wonder on 21 Oct 2019
FDA approves new breakthrough therapy for cystic fibrosis
21 October 2019 - Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic ...