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RSS FeedPosted by Michael Wonder on 21 Dec 2017
FDA accepts new drug application for Seysara (sarecycline) for the treatment of moderate to severe acne
20 December 2017 - Allergan and Paratek Pharmaceuticals today announced that the U.S. FDA has accepted a new drug application to ...
Posted by Michael Wonder on 21 Dec 2017
Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers
20 December 2017 - Completion of NDA submission expected in early 2018. ...
Posted by Michael Wonder on 21 Dec 2017
FDA approves Genentech’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
20 December 2017 - Accelerated approval of Perjeta for neo-adjuvant use also converted to full approval. ...
Posted by Michael Wonder on 21 Dec 2017
Aeterna Zentaris announces FDA approval of Macrilen (macimorelin) for diagnosis of adult growth hormone deficiency
20 December 2017 - Aeterna Zentaris announced today that the U.S. FDA has granted marketing approval for Macrilen (macimorelin), an orally ...
Posted by Michael Wonder on 21 Dec 2017
The Regulatory Accountability Act of 2017 — implications for FDA regulation and public health
20 December 2017 - In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme ...
Posted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018. ...
Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated ...
Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018. ...
Posted by Michael Wonder on 20 Dec 2017
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously untreated advanced renal cell carcinoma
19 February 2017 - Approval expands indication and comes well in advance of PDUFA date of 15 February 2018. ...
Posted by Michael Wonder on 20 Dec 2017
U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly-diagnosed PH+ chronic myelogenous leukaemia (CML)
19 December 2017 - Pfizer's third U.S. haematology approval in five months. ...
Posted by Michael Wonder on 19 Dec 2017
Guidelines for statistical analysis plans
19 December 2017 - The emergence of the randomised clinical trial as the gold standard for the evaluation of new clinical ...
Posted by Michael Wonder on 19 Dec 2017
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Angelman syndrome
19 December 2017 - Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the ...
Posted by Michael Wonder on 19 Dec 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
19 December 2017 - Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations ...
Posted by Michael Wonder on 19 Dec 2017
Republican bill to reduce tax credits for rare disease drugs
18 December 2017 - The target comes as a surprise under a Republican administration that has shown little interest in addressing ...
Posted by Michael Wonder on 19 Dec 2017
Aerie Pharmaceuticals announces U.S. FDA approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
18 December 2017 - Product approved ahead of the Scheduled PDUFA date of 28 February 2018. ...