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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Sep 2019
Biosimilars Forum’s public letter in response to anti-biosimilars Op-Ed
29 August 2019 - Government Should Not “Throw In the Towel on Biosimilars,” They Should Act Now to Unlock Billions ...
Posted by Michael Wonder on 02 Sep 2019
Genentech provides update on supplemental biologics licence application for Tecentriq in first-line metastatic non-squamous non-small cell lung cancer
30 August 2019 - Genentech was notified by the U.S. FDA that the review period for the supplemental biologics license application ...
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 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 29 Aug 2019
Academics and consumer groups protest FDA plan to summarise review documents
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
Posted by Michael Wonder on 29 Aug 2019
Are reasonable restraints on drug price increases doomed by pharma lobbying?
29 August 2019 - In a rare but important display of congressional bipartisanship, Senators Chuck Grassley (R-Iowa) and Ron Wyden ...
Posted by Michael Wonder on 29 Aug 2019
Zensun announces the investigation of Neucardin for chronic heart failure receives fast track designation from the US FDA
26 August 2019 - Zensun announced that the investigation of Neucardin, its recombinant human neuregulin-1 fragment, has received fast track designation ...
Posted by Michael Wonder on 29 Aug 2019
Emalex Biosciences receives FDA fast track designation for ecopipam for the treatment of patients with Tourette syndrome
28 August 2019 - Emalex Biosciences announced today that it has received fast track designation for its investigational product, ecopipam, from ...
Posted by Michael Wonder on 28 Aug 2019
Promoting paediatric drug research and labelling — outcomes of legislation
28 August 2019 - Congress has modified regulations of the FDA to promote research assessing the efficacy and safety of drugs ...