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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Oct 2019
FDA grants breakthrough therapy designation to cobimetinib for MEK inhibition in histiocytic neoplasms, research led by MSK
2 October 2019 - Memorial Sloan Kettering Cancer Center announced today that the US FDA has granted a breakthrough therapy designation ...
Posted by Michael Wonder on 04 Oct 2019
Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer
3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant ...
Posted by Michael Wonder on 25 Sep 2019
Achillion receives breakthrough therapy designation from FDA for danicopan for treatment of paroxysmal nocturnal hemoglobinuria
25 September 2019 - Achillion Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for danicopan (ACH-4471) for ...
Posted by Michael Wonder on 18 Sep 2019
FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis
18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...
Posted by Michael Wonder on 12 Sep 2019
When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates
11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...
Posted by Michael Wonder on 11 Sep 2019
Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations
11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...
Posted by Michael Wonder on 07 Sep 2019
Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114
6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, ...
Posted by Michael Wonder on 06 Sep 2019
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer
6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...
Posted by Michael Wonder on 03 Sep 2019
Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults
3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational ...
Posted by Michael Wonder on 30 Aug 2019
SpringWorks Therapeutics receives breakthrough therapy designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours
29 August 2019 - SpringWorks Therapeutics today announced the U.S. FDA has granted breakthrough therapy designation for nirogacestat, an oral, selective, ...
Posted by Michael Wonder on 20 Aug 2019
Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection
20 August 2019 - Fourth Eiger program granted breakthrough therapy designation. ...