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RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 Jun 2024
Adtralza (tralokinumab) pre-filled pen now available in Canada
12 June 2024 - The single-use 2 mL pre-filled pen is an additional injection choice for administering Adtralza for the ...
Posted by Michael Wonder on 13 Jun 2024
FDA approves selpercatinib for RET fusion positive thyroid cancer
12 June 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 12 Jun 2024
Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus
12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...
Posted by Michael Wonder on 11 Jun 2024
Calico Life Sciences announces that fosigotifator (ABBV-CLS-7262) for vanishing white matter disease has been selected for the FDA START pilot program
7 June 2024 -- Calico Life Sciences today announced that its investigational eIF2B activator fosigotifator (ABBV-CLS-7262) has been accepted into ...
Posted by Michael Wonder on 11 Jun 2024
Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis
11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...
Posted by Michael Wonder on 11 Jun 2024
Ipsen’s Iqirvo receives US FDA accelerated approval as a first in class PPAR treatment for primary biliary cholangitis
10 June 2024 - Approval based on positive Phase 3 ELATIVE trial data. ...
Posted by Michael Wonder on 10 Jun 2024
FDA grants fast track designation to GCBP and Novel Pharma's GC1130A
10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jun 2024
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance
10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...
Posted by Michael Wonder on 10 Jun 2024
FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2
10 June 2024 - Original FDA approval (December 2020) now extended to the use of Klisyri on larger areas of the ...