Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
FDA approves neo-adjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
3 October 2024 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neo-adjuvant treatment, followed ...
Posted by Michael Wonder on 30 Sep 2024
Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)
30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...
Posted by Michael Wonder on 30 Sep 2024
FDA approves imaging drug for evaluation of myocardial ischaemia and infarction
27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...
Posted by Michael Wonder on 29 Sep 2024
Dupixent (dupilumab) approved in the US as the first ever biologic medicine for patients with COPD
27 September 2024 - Following recent approvals in the EU and China, the US approval is based on two landmark Phase ...
Posted by Michael Wonder on 29 Sep 2024
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
27 September 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 27 Sep 2024
FDA approves drug with new mechanism of action for treatment of schizophrenia
26 September 2024 - Today, the US FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves new drug to treat Niemann-Pick disease, type C
24 September 2024 - Today, the US FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...
Posted by Michael Wonder on 23 Sep 2024
UCB announces US FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis
23 September 2024 - With three new indications, Bimzelx (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves nasal spray influenza vaccine for self or caregiver administration
20 September 2024 - First influenza vaccine that does not need to be administered by a health care provider. ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
20 September 2024 - Today, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves first treatment for Niemann-Pick disease, type C
20 September 2024 - Today, the US FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type ...
Posted by Michael Wonder on 19 Sep 2024
FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
19 September 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for adult patients with locally ...
Posted by Michael Wonder on 19 Sep 2024
FDA declines to approve Vanda's marketing application for tradipitant in gastroparesis
19 September 2024 - - Vanda Pharmaceuticals today provided an update on its tradipitant development program. ...
Posted by Michael Wonder on 18 Sep 2024
Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
18 September 2024 - New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and ...