Blog
RSS FeedPosted by Michael Wonder on 02 Jun 2017
Roche announces FDA approval of companion diagnostic to identify ALK positive non-small-cell lung cancer patients
1 June 2017 - The Ventana ALK CDx assay identifies ALK positive non-small-cell lung cancer patients eligible for treatment with the ...
Posted by Michael Wonder on 02 Jun 2017
Spinraza (nusinersen) approved in the European Union as first treatment for spinal muscular atrophy
1 June 2017 - Robust data from phase 3 studies demonstrated positive impact on motor milestone achievement; increased survival in infants ...
Posted by Michael Wonder on 01 Jun 2017
Swissmedic touts 2016 performance: 42 new approvals
30 May 2017 - In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the EMA and ...
Posted by Michael Wonder on 01 Jun 2017
Novo Nordisk receives US FDA approval of Rebinyn (nonacog beta pegol; N9-GP)
31 May 2017 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Rebinyn ...
Posted by Michael Wonder on 01 Jun 2017
Nicox receives FDA approval of Zerviate (cetirizine ophthalmic solution) 0.24%
31 May 2017 - U.S. patent protection until at least 2030. ...
Posted by Michael Wonder on 31 May 2017
ProQR receives fast track designation from the FDA for QR-110 for Leber’s congenital amaurosis type 10
31 May 2017 - QR-110 is currently in clinical development with the planned Phase 1/2 open-label trial (PQ-110-001) that will assess ...
Posted by Michael Wonder on 31 May 2017
FDA grants breakthrough therapy designation for Alnylam's givosiran for the prophylaxis of attacks in patients with acute hepatic porphyria
31 May 2017 - Company plans to initiate Phase 3 clinical program in late 2017. ...
Posted by Michael Wonder on 31 May 2017
Kineret approved in Canada for the treatment of neonatal-onset multisystem inflammatory disease (NOMID)
30 May 2017 - Sobi Canada today announces that Health Canada has approved Kineret (anakinra) for the treatment of neonatal-onset ...
Posted by Michael Wonder on 31 May 2017
Merck receives FDA approval of Isentress HD (raltegravir), a new once daily option, in combination with other anti-retroviral agents, for the treatment of HIV-1 infection in appropriate patients
30 May 2017 - Merck today announced that the U.S. FDA has approved Isentress HD, a new 1200 mg once-daily dose ...
Posted by Michael Wonder on 31 May 2017
European Commission approves Pfizer's Trumenba to help prevent meningococcal Group B disease in adolescents and adults
30 May 2017 - Trumenba approved in Europe with option for a two or three dose schedule. ...
Posted by Michael Wonder on 30 May 2017
FDA approves first generic Strattera for the treatment of ADHD
30 May 2017 - The U.S. FDA today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder ...
Posted by Michael Wonder on 28 May 2017
Sunovion receives complete response letter from FDA for SUN-101/eFlow (glycopyrrolate) new drug application for chronic obstructive pulmonary disease
26 May 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 27 May 2017
Piramal Imaging and IsoLogic Innovative Radiopharmaceuticals announce commercial approval of Neuraceq by Health Canada
28 February 2017 - Piramal Imaging and IsoLogic Innovative Radiopharmaceuticals today announce that Health Canada has issued a Notice of ...
Posted by Michael Wonder on 27 May 2017
Drug approvals bounce back as R&D labs churn out new winners
25 May 2017 - The number of new drugs approved for sale in United States and Europe has bounced back ...
Posted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with ...