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RSS FeedPosted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission ...
Posted by Michael Wonder on 30 Nov 2021
The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain
30 November 2021 - Camurus today announces that the EMA has accepted the company’s submission of a Type II variation application ...
Posted by Michael Wonder on 30 Nov 2021
Lynparza granted priority review in the US for BRCA mutated HER2 negative high risk early breast cancer
30 November 2021 - First medicine targeting BRCA mutations to show clinical benefit in adjuvant setting. ...
Posted by Michael Wonder on 30 Nov 2021
Caldolor now FDA approved for pre-operative administration
29 November 2021 - Dosed prior to surgery, Caldolor demonstrated significant reduction in pain intensity. ...
Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves Bayer's Verquvo
29 November 2021 - Verquvo has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 29 Nov 2021
FDA approves new imaging drug to help identify ovarian cancer lesions
29 November 2021 - The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves new medicines for patients with graft versus host disease
26 November 2021 - Rholistiq is Kadmon's first product to be approved in Australia. ...
Posted by Michael Wonder on 29 Nov 2021
U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition
18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per ...
Posted by Michael Wonder on 29 Nov 2021
Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive
29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...
Posted by Michael Wonder on 29 Nov 2021
Fennec Pharmaceuticals expects to receive complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours
29 November 2021 - FDA pre-approval inspection identified deficiencies with the facility of the drug product manufacturer, which require resolution prior ...
Posted by Michael Wonder on 27 Nov 2021
Shingrix approved in Canada for adults at increased risk of shingles due to immunodeficiency or immunosuppression
25 November 2021 - GlaxoSmithKline today announced that Shingrix (Zoster Vaccine Recombinant, Adjuvanted) has been approved in Canada for the prevention ...
Posted by Michael Wonder on 26 Nov 2021
European Commission approves Byannli (6 monthly paliperidone palmitate) for the maintenance treatment of schizophrenia in adults
23 November 2021 - The approval is based on results from the Route 6 Study, which showed that 92.5 percent ...