The $49M in Series A funding will be used to develop the company's enzyme replacement therapies for two rare diseases affecting infants and children and push the treatments into the…
The transaction is expected to close by the end of Cardinal Health's fiscal year, subject to closing conditions and regulatory clearances. Source: BioSpace
In what seems to be part of the lead up to the departure of the UK from the European Union, the European Medicines Agency laid out how sponsors holding orphan…
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August…
The FDA granted its first-ever approval to a prescription pill containing a sensor that verifies ingestion via electronic detection. Source: Drug Industry Daily
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic…
Investors love to speculate on M&A, and one of the hottest topics of speculation recently has been whether someone will buy BMS. Source: BioSpace
Two days after Mylan CEO Heather Bresch said she sees a "strong finish" for the company through the rest of 2017, the company has reportedly let between 200 and 300…
Beleaguered Avinger, is slashing more jobs. Source: BioSpace
Novartis is not resting on the laurels of having the first-ever-approval for a CAR-T cancer drug, Kymriah. Source: BioSpace