15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
15 November 2017 - The U.S. FDA today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an ...
6 November 2017 - FDA expands approval of Zelboraf (vemurafenib) to treat certain adult patients with Erdheim-Chester Disease, a rare cancer ...
1 November 2017 - ArQule today announced that the U.S. FDA has granted rare paediatric disease designation to miransertib (ARQ ...
26 October 2017 - Atara Biotherapeutics today announced that ATA230 was granted rare paediatric disease designation for the treatment of ...
25 October 2017 - PTC Therapeutics today announced that the Office of Drug Evaluation I of the U.S. FDA has ...
10 October 2017 - One pharma company’s medicine illustrates how firms can benefit from different layers of market-exclusivity protections. ...
6 October 2017 - The U.S. FDA today announced it has awarded six new research grants for natural history studies ...
6 October 2017 - The U.S. FDA today announced that it has awarded 15 new clinical trial research grants totalling ...
19 September 2017 - New drug application submission on track for 4Q17. ...
12 September 2017 - Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, ...
12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests ...
5 September 2017 - Sobi has received approval from the U.S. FDA for a reduced dosing frequency for Orfadin (nitisinone) ...
5 September 2017 - Global Blood Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation to GBT440 ...
1 August 2017 - Vertex Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Kalydeco (ivacaftor) ...