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RSS FeedPosted by Michael Wonder on 29 Dec 2020
Lorbrena (lorlatinib) supplementary new drug application in previously untreated ALK positive lung cancer accepted for priority review by U.S. FDA
28 December 2020 - Supplemental new drug application being reviewed under FDA Real-Time Oncology Review and Project ORBIS pilot programs. ...
Posted by Michael Wonder on 29 Dec 2020
Cara Therapeutics submits new drug application to U.S. FDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
28 December 2020 - First NDA submission for Company’s lead program, Korsuva injection. ...
Posted by Michael Wonder on 29 Dec 2020
FDA approves first generic of drug used to treat severe hypoglycaemia
28 December 2020 - Today, the U.S. FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged in ...
Posted by Michael Wonder on 28 Dec 2020
Chi-Med initiates rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
28 December 2020 - Company plans to complete rolling submission in the first half of 2021. ...
Posted by Michael Wonder on 28 Dec 2020
Imbruvica (ibrutinib) U.S. Prescribing Information updated to include long-term data for Waldenström's macroglobulinemia
23 December 2020 - Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated ...
Posted by Michael Wonder on 27 Dec 2020
FDA acceptance for the filing of new drug application
23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...
Posted by Michael Wonder on 27 Dec 2020
Dr. Reddy's Laboratories, Global Response Aid, and Appili Therapeutics announce the filing of an application for Reeqonus (favipiravir) tablets for the treatment of COVID-19 under Health Canada’s Interim Order
22 December 2020 - Dr. Reddy’s Laboratories, Appili Therapeutics and Global Response Aid today announced that Dr. Reddy’s Canada has ...
Posted by Michael Wonder on 27 Dec 2020
Pandemic delays FDA decision on Biocon's bevacizumab application
27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its ...
Posted by Michael Wonder on 26 Dec 2020
Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
Posted by Michael Wonder on 26 Dec 2020
Canada approves the Moderna vaccine, paving the way for inoculations in its vast far north
23 December 2020 - Canada’s regulator approved Moderna’s vaccine on Wednesday, a move that will make it easier to inoculate ...
Posted by Michael Wonder on 26 Dec 2020
Sumitovant Biopharma announces Urovant Sciences receives U.S. FDA approval of Gemtesa (vibegron) 75 mg tablets for the treatment of patients with overactive bladder
23 December 2020 - Sumitovant Biopharma today announced that Urovant Sciences has received U.S. FDA approval of its new drug application ...
Posted by Michael Wonder on 23 Dec 2020
FDA approves Bracco Diagnostics' ProHance (gadoteridol) Injection, 279.3 mg/mL, for paediatric patients younger than two years
23 December 2020 - Bracco Diagnostics today announced that the U.S. FDA has approved ProHance (gadoteridol 279.3 mg/mL injection) for ...
Posted by Michael Wonder on 23 Dec 2020
Pfizer to supply US with additional 100 million vaccine doses
24 December 2020 - Pfizer says it will supply the US government with an additional 100 million doses of its ...
Posted by Michael Wonder on 23 Dec 2020
The European Commission approves Zogenix’s Fintempa (fenfluramine) oral solution for the treatment of seizures in Dravet syndrome
21 December 2020 - First EU market launch planned for Germany in Q1 2021. ...
Posted by Michael Wonder on 23 Dec 2020
Occlutech’s atrial flow regulator receives U.S. FDA breakthrough device designation
18 December 2020 - Occlutech announced today that the US FDA has granted the company a breakthrough device designation for its ...