Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
Life-saving cystic fibrosis miracle drug stuck in limbo
28 December 2020 - Lyla Gillard was diagnosed with cystic fibrosis, a deadly genetic disease that affects the lungs and ...
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 28 Dec 2020
PBS listings bring greater hope in fight against multiple myeloma and severe psoriasis
28 December 2020 - Critical new medicines have been listed on the Pharmaceutical Benefits Scheme, including to fight one of the ...
Posted by Michael Wonder on 28 Dec 2020
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
28 December 2020 - Approvals based on the PAOLA-1, PROfound and POLO Phase III trials ...
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 ...