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RSS FeedPosted by Michael Wonder on 20 Sep 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...
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
Daiichi Sankyo’s Vanflyta recommended by NICE for acute myeloid leukaemia
19 September 2024 - Daiichi Sankyo’s Vanflyta (quizartinib) has been recommended by NICE for certain cases of acute myeloid leukaemia. ...
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 17 Sep 2024
Rucaparib camsylate for the maintenance treatment of patients with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer (final guidance)
17 September 2024 - NICE has published final evidence-based recommendations on the use of rucaparib camsylate (Rubraca) for the maintenance ...
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 13 Sep 2024
Sanofi/Regeneron’s Dupixent approved by MHRA to treat uncontrolled COPD
12 December 2024 - Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the MHRA as an add-on maintenance treatment ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab injection) approved in Canada for the treatment of children aged 1 year and older with eosinophilic oesophagitis
12 September 2024 - This is the ninth indication for Dupixent in Canada and its second in gastroenterology. ...
Posted by Michael Wonder on 13 Sep 2024
Health Canada approves Keytruda as monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options
12 September 2024 - Merck announced that Health Canada has granted approval of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy ...
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, ...