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RSS FeedPosted 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 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...
Posted by Michael Wonder on 05 Sep 2019
Is the FDA out to get this $2.9 billion diabetes drug class?
6 September 2019 - In March, the FDA issued a complete response letter -- the agency's euphemism for a rejection ...
Posted by Michael Wonder on 05 Sep 2019
GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease
5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...
Posted by Michael Wonder on 05 Sep 2019
Texas Doctor Stephen M. Hahn is a top contender to head FDA
4 September 2019 - M.D. Anderson’s radiation-oncology chief is among three leading candidates for post open since April. ...
Posted by Michael Wonder on 05 Sep 2019
Tricida announces submission of new drug application for veverimer for the treatment of metabolic acidosis in patients with chronic kidney disease
4 September 2019 - New drug application submitted under the FDA’s accelerated approval program. ...
Posted by Michael Wonder on 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...
Posted by Michael Wonder on 04 Sep 2019
Releasing the potential of real world evidence
4 September 2019 - Janssen believes RWE could realise an efficient, personalised and truly patient-centric health care system. ...
Posted by Michael Wonder on 04 Sep 2019
Forty Seven granted fast track designation for magrolimab for the treatment of myelodysplastic syndrome and acute myeloid leukaemia
3 September 2019 - Forty Seven today announced that the U.S. FDA has granted fast track designation to magrolimab (formerly known ...
Posted by Michael Wonder on 04 Sep 2019
GeneTx and Ultragenyx announce orphan drug designation and rare paediatric disease designation for GTX-102
3 September 2019 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted orphan drug designation and rare ...
Posted by Michael Wonder on 04 Sep 2019
Inotrem announces fast track designation granted by U.S. FDA to nangibotide development program for the treatment of septic shock
4 September 2019 - Inotrem announced today that the U.S. FDA has granted fast track designation to nangibotide development program for ...
Posted by Michael Wonder on 03 Sep 2019
Mylan and Biocon get a second complete response letter for insulin glargine follow-on
3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second ...
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 03 Sep 2019
The FDA and Sarepta: a window into the real world of drug regulation
3 September 2019 - It is hard to discern the true state of drug regulation from the outside, but two ...