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RSS FeedPosted by Michael Wonder on 22 Dec 2018
Aimmune Therapeutics submits BLA to FDA for AR101 for the treatment of peanut allergy in children and adolescents ages 4–17
21 December 2018 - Aimmune Therapeutics today announced that it has submitted a biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 22 Dec 2018
Dealing with drug pricing: not just one solution
22 December 2018 - On 11 December, US FDA Commissioner Scott Gottlieb announced a set of rules that would change the ...
Posted by Michael Wonder on 21 Dec 2018
FDA approves new treatment for adult patients with rare, life-threatening blood disease
21 December 2018 - The U.S. FDA today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal ...
Posted by Michael Wonder on 21 Dec 2018
FDA approves first treatment for rare blood disease
21 December 2018 - The U.S. FDA today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm ...
Posted by Michael Wonder on 21 Dec 2018
Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease
20 December 2018 - AstraZeneca today announced that the European Commission has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose ...
Posted by Michael Wonder on 21 Dec 2018
Merck provides update on Keytruda (pembrolizumab) supplemental biologics license application for KEYNOTE-042 trial
20 December 2018 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics license ...
Posted by Michael Wonder on 21 Dec 2018
Janssen announces European Commission approval of Darzalex (daratumumab) split dosing regimen
20 December 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted ...
Posted by Michael Wonder on 21 Dec 2018
Nabriva Therapeutics submits new drug applications to U.S. FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
20 December 2018 - Nabriva Therapeutics announced the submission of two new drug applications to the U.S. FDA for the ...
Posted by Michael Wonder on 20 Dec 2018
Dengvaxia vaccine approved for prevention of dengue in Europe
19 December 2018 - The European Commission has granted marketing authorization for Dengvaxia®, Sanofi’s dengue vaccine. ...
Posted by Michael Wonder on 20 Dec 2018
AbbVie submits new drug application to U.S. FDA and marketing authorisation application to EMA for upadacitinib for treatment of adults with moderate to severe rheumatoid arthritis
20 December 2018 - Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to ...
Posted by Michael Wonder on 20 Dec 2018
Pharmaxis announces resubmission of Bronchitol NDA in USA
18 December 2018 - Pharmaxis today announced the resubmission of the Bronchitol new drug application with the United States FDA ...
Posted by Michael Wonder on 20 Dec 2018
Biosimilar trastuzumab co-developed by Biocon receives approval in the EU
19 December 2018 - Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. ...
Posted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
Posted by Michael Wonder on 20 Dec 2018
Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders
19 December 2018 - Designation is seventh for Chugai originated drug. ...
Posted by Michael Wonder on 20 Dec 2018
FDA approves new indication for Envarsus XR (tacrolimus extended-release tablets)
19 December 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA approved a new indication for Envarsus XR (tacrolimus ...