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RSS FeedPosted by Michael Wonder on 20 Nov 2023
Janssen submits supplemental biologics license application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus chemotherapy for the treatment of patients with EGFR mutated non-small-cell lung cancer who progressed on or after osimertinib
20 November 2023 - This submission is supported by data from the Phase 3 MARIPOSA-2 Study featured in a Late-Breaking Presidential ...
Posted by Michael Wonder on 11 Aug 2023
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer
11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), ...
Posted by Michael Wonder on 14 Jul 2023
Health Canada approves Lynparza in combination with abiraterone and prednisone or prednisolone for patients with BRCA mutated metastatic castration-resistant prostate cancer
13 July 2023 - Conditional approval based on data from Phase 3 PROpel trial. ...
Posted by Michael Wonder on 21 Jun 2023
Teikoku Pharma granted FDA fast track designation for TPU-006, a novel 4 day dexmedetomidine transdermal system for post operative pain management
21 June 2023 - Teikoku Pharma today announced that the US FDA granted fast track designation for TPU-006 in managing post-operative ...
Posted by Michael Wonder on 23 May 2023
US FDA approves the Cyltezo Pen, a new auto-injector option, ahead of 1 July commercial launch
22 May 2023 - Cyltezo (adalimumab-adbm) will be commercially available in the US beginning on 1 July 2023. ...
Posted by Michael Wonder on 23 Feb 2023
US Medicare says no change to Alzheimer's drug restrictions
23 February 2023 - The US Government health plan for people over the age of 65 on Wednesday said it ...
Posted by Michael Wonder on 17 Feb 2023
Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
17 February 2023 - Eisai anticipates about 100,000 patients diagnosed will be eligible for the drug by year three of its ...
Posted by Michael Wonder on 07 Feb 2023
Miracle’ cystic fibrosis drug kept out of reach in developing countries
7 February 2023 - Vertex Pharmaceuticals is not making its drug, Trikafta, available in poorer countries, where thousands of diagnosed patients ...
Posted by Michael Wonder on 31 Jan 2023
Medicare drug price negotiation in the United States: implications and unanswered questions
8 December 2022 - The United States is a relatively free pricing market for pharmaceutical manufacturers to set list prices at ...
Posted by Michael Wonder on 17 Oct 2022
Calls for TGA to withdraw Covid drug approval
17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...
Posted by Michael Wonder on 03 Aug 2022
FDA approves Coherus’ Cimerli (ranibizumab-eqrn) as the first and only interchangeable biosimilar to Lucentis for all five indications, with 12 months of interchangeability exclusivity
2 August 2022 - First Cimerli product sales expected in October 2022. ...
Posted by Michael Wonder on 30 May 2022
Why won’t the FDA let doctors prescribe fluvoxamine for COVID?
30 May 2022 - Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use. ...
Posted by Michael Wonder on 19 Apr 2022
Medicare’s decision not to fund Aduhelm changes landscape for US pharma industry
19 April 2022 - The decision by the agency responsible for Medicare to restrict coverage of Biogen’s Alzheimer’s drug aducanumab ...
Posted by Michael Wonder on 24 Nov 2021
Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
23 November 2021 - Robert Califf, President Biden’s choice to lead the FDA, earned $2.7 million as an executive at ...
Posted by Michael Wonder on 06 Apr 2021
United Therapeutics announces FDA approval and launch of Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease
1 April 2021 - First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening ...