COVID-19 1275 Views The FDA is postponing most foreign inspections in response to the coronavirus outbreak Malin Otmani March 12, 2020 FDA has provided an update …
Global report 1714 Views EU-US collaboration to combat rare diseases Malin Otmani October 5, 2016 The European Medicines Agency (EMA) …
In a new job 1767 Views Robert Califf named FDA Deputy Commissioner for Medical Products Malin Otmani March 9, 2016 U.S. Food and Drug Administration …
Drug Development Pharma 2183 Views Orexo’s ZUBSOLV approved Malin Otmani August 17, 2015 Orexo has announced that the …
MedTech Business 1514 Views Elekta receives US 510(k) clearance Malin Otmani August 10, 2015 Elekta’s Leksell Gamma Knife® Icon™ …
Drug Development Pharma 1931 Views Janssen Submits BLA to FDA Ellen R. Delisio June 9, 2015 Genmab A/S’s licensing partner Janssen …
Companies 1520 Views FDA Investigating Type 2 Diabetes Drugs Ellen R. Delisio May 20, 2015 The U.S. Food and Drug …
Drug Development Pharma 1443 Views More Good News for Kidney Transplant Drug Ellen R. Delisio April 22, 2015 Trials of once-daily Envarsus® XR, …
Drug Development Pharma 1515 Views FDA Accepts Novo Resubmission Ellen R. Delisio April 9, 2015 The US Food and Drug …
Clinical Trials 2027 Views Clanotech Drug Gets FDA Orphan Label Ellen R. Delisio March 30, 2015 Clanotech AB’s candidate drug CLT-28643 …
Clinical Trials 1490 Views Novo to Resubmit Drugs to FDA Ellen R. Delisio March 27, 2015 Novo Nordisk has decided to …
Business article 2086 Views SEC: Keep up With Compliance, Disclosures Ellen R. Delisio March 2, 2015 Shoring up compliance and disclosure …
Intellectual Property 1619 Views FDA, Veloxis Dispute Continues Ellen R. Delisio February 5, 2015 The U.S. Food and Drug …
Clinical Trials 1915 Views Astra’s Brilinta Gets a Boost Ellen R. Delisio January 22, 2015 On the heels of positive outcomes …
Regulatory compliance 1782 Views Veloxis Responds to Court Order Ellen R. Delisio December 22, 2014 Veloxis Pharmaceuticals A/S commented on …
Companies 1628 Views Veloxis Files Suit Against FDA Ellen R. Delisio December 18, 2014 Denmark’s Veloxis Pharmaceuticals A/S announced …
