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RSS FeedPosted by Michael Wonder on 19 Jun 2024
US FDA approves Skyrizi (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie's portfolio across inflammatory bowel disease
18 June 2024 - Approval supported by two Phase 3 clinical trials that evaluated Skyrizi for the treatment of moderate to ...
Posted by Michael Wonder on 18 Jun 2024
Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies
17 June 2024 - Launching Yimmugo in the US will over time significantly add to Grifols Group sales and underpins ...
Posted by Michael Wonder on 18 Jun 2024
US FDA rare paediatric disease designation granted to RC220 bisantrene for the treatment of paediatric AML
18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...
Posted by Michael Wonder on 18 Jun 2024
Subcutaneous amivantamab biologics license application submitted to US FDA for patients with EGFR mutated non-small-cell lung cancer
17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration ...
Posted by Michael Wonder on 18 Jun 2024
US FDA approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...
Posted by Michael Wonder on 17 Jun 2024
Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate
17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...
Posted by Michael Wonder on 17 Jun 2024
FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma
17 June 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for ...
Posted by Michael Wonder on 15 Jun 2024
Blue Cross Blue Shield of Michigan dropping coverage of weight loss drugs
14 June 2024 - Michigan's largest insurance company said it will begin eliminating coverage of various weight loss drugs next ...
Posted by Michael Wonder on 15 Jun 2024
Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
Posted by Michael Wonder on 14 Jun 2024
FDA approves blinatumomab as consolidation for CD19 positive Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia
14 June 2024 - Today, the FDA approved blinatumomab (Blincyto, Amgen) for adult and paediatric patients one month and older ...
Posted by Michael Wonder on 14 Jun 2024
FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer
14 June 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with carboplatin plus paclitaxel followed by single-agent durvalumab for ...
Posted by Michael Wonder on 13 Jun 2024
FDA approves Adbry (tralokinumab-ldrm) auto-injector for the treatment of adults with moderate to severe atopic dermatitis
13 June 2024 - Single-dose auto-injector will provide adult patients in the US with an alternative method of administration for Adbry, ...
Posted by Michael Wonder on 13 Jun 2024
FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...
Posted by Michael Wonder on 13 Jun 2024
Receipt of complete response letter from US FDA for ND0612
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 13 Jun 2024
Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC ...