Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
17 September 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
17 September 2024 - Today, the FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate to severe atopic dermatitis
13 September 2024 - Ebglyss provides a new first-line biologic treatment for moderate to severe atopic dermatitis that is not well ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Ocrevus Zunovo as the first and only twice a year 10 minute subcutaneous injection for people with relapsing and progressive multiple sclerosis
13 September 2024 - Ocrevus Zunovo has the potential to expand treatment options to centres without intravenous infrastructure or with intravenous ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab) approved in the US as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps
13 September 2024 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) as an add-on ...
Posted by Michael Wonder on 12 Sep 2024
FDA authorises first over the counter hearing aid software
12 September 2024 - Today, the US FDA authorised the first over the counter hearing aid software device, Hearing Aid Feature, ...
Posted by Michael Wonder on 12 Sep 2024
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
12 September 2024 - Today, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection for all the ...