Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 22 Jan 2025
Abiraterone acetate with niraparib tosylate monohydrate and prednisone for untreated hormone-relapsed metastatic prostate cancer
22 January 2025 - NICE is unable to make a recommendation about the use in the NHS of niraparib with abiraterone ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 22 Jan 2025
Bluejay Therapeutics receives US FDA breakthrough therapy designation for brelovitug (BJT-778) for the treatment of chronic hepatitis delta
21 January 2025 - Bluejay Therapeutics today announced that its lead product candidate brelovitug (also known as BJT-778) has received ...
Posted by Michael Wonder on 22 Jan 2025
Nacuity Pharmaceuticals granted US FDA fast track designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
21 January 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted fast track designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 21 Jan 2025
Dyne Therapeutics receives FDA fast track designation for DYNE-101 for the treatment of myotonic dystrophy type 1
21 January 2025 - Dyne Therapeutics today announced that the US FDA has granted fast track designation for DYNE-101 for ...
Posted by Michael Wonder on 21 Jan 2025
Solid Biosciences receives FDA fast track designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
21 January 2025 - Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and ...
Posted by Michael Wonder on 21 Jan 2025
Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis
21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...
Posted by Michael Wonder on 21 Jan 2025
NICE has made six times more lung cancer treatment recommendations over the past ten years than in the previous decade
21 January 2025 - We have also recommended osimertinib for routine use on the NHS today. ...
Posted by Michael Wonder on 21 Jan 2025
Spravato (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
21 January 2024 - Following US FDA priority review, approval is based on data demonstrating Spravato alone met its primary endpoint ...
Posted by Michael Wonder on 21 Jan 2025
European Commission approves Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
21 January 2025 - Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen ...
Posted by Michael Wonder on 21 Jan 2025
Anti-PD-L1 tagitanlimab approved for marketing by the National Medical Products Administration
20 January 2025 - The board of directors of Sichuan Kelun-Biotech Biopharmaceutical is pleased to announce that the Company received ...
Posted by Michael Wonder on 21 Jan 2025
Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama
20 January 2025 - Teva Pharmaceuticals will semi-exclusively market FYB203 under the brand name Ahzantive in major parts of Europe. ...
Posted by Michael Wonder on 21 Jan 2025
Drug shortage crisis demands intervention, AMA warns, as patients struggle to secure medicines
20 January 2025 - There are more than 400 medicine shortages, and the country’s leading medical group blames it on ‘ad ...
Posted by Michael Wonder on 21 Jan 2025
Albertan with rare blood cancer calls on Health Canada to approve life-saving drug
20 January 2025 - An Alberta woman living with a rare form of blood cancer is calling on Health Canada ...
Posted by Michael Wonder on 21 Jan 2025
Takeda's Fruzaqla (fruquintinib) receives Health Canada market authorisation for metastatic colorectal cancer
20 January 2025 - Positive reimbursement recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux. ...