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RSS FeedPosted by Michael Wonder on 24 Oct 2023
FDA approves ivosidenib for myelodysplastic syndromes
24 October 2023 - Today, the FDA approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for adult patients with relapsed or refractory myelodysplastic ...
Posted by Michael Wonder on 23 Oct 2023
Celltrion USA announces US FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease
22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment ...
Posted by Michael Wonder on 23 Oct 2023
FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older
20 October 2023 - First and only FDA approved fixed dose, triple combination topical treatment. ...
Posted by Michael Wonder on 23 Oct 2023
Zydus receives US FDA approval for Zituvio to treat adult patients with type 2 diabetes mellitus
20 October 2023 - The company received final approval from the US FDA for its new drug application for Zituvio ...
Posted by Michael Wonder on 22 Oct 2023
US Food and Drug Administration approves BioMarin's Voxzogo (vosoritide) for children under 5 years with achondroplasia
20 October 2023 - Expanded indication in the US now includes children of all ages with achondroplasia. ...
Posted by Michael Wonder on 21 Oct 2023
FDA approves Penbraya, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents
20 October 2023 - The FDA’s decision is based on data from Phase 2 and Phase 3 trials, which demonstrated that ...
Posted by Michael Wonder on 20 Oct 2023
Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria
20 October 2023 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 19 Oct 2023
Orasis Pharmaceuticals announces FDA approval of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia
18 October 2023 - Qlosi is a preservative free, low dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and ...
Posted by Michael Wonder on 18 Oct 2023
Hyloris announces US FDA approval of Maxigesic IV
18 October 2023 - Maxigesic IV, a potent non-opioid painkiller, to be marketed in the US under the tradename Combogesic IV. ...
Posted by Michael Wonder on 18 Oct 2023
FDA approves Xphozah (tenapanor), a first in class phosphate absorption inhibitor
17 October 2023 - Commercial launch underway with product expected to be available in November. ...
Posted by Michael Wonder on 18 Oct 2023
Bimzelx approved by the US FDA for the treatment of adults with moderate to severe plaque psoriasis
18 October 2023 - Approval is supported by three Phase 3 trials where bimekizumab consistently delivered fast, complete and lasting levels ...
Posted by Michael Wonder on 17 Oct 2023
UCB announces US FDA approval of Zilbrysq (zilucoplan) for the treatment of adults with generalised myasthenia gravis
17 October 2023 - US FDA approval of zilucoplan is built on the pivotal Phase 3 RAISE study in generalised myasthenia ...
Posted by Michael Wonder on 16 Oct 2023
FDA approves neo-adjuvant/adjuvant pembrolizumab for resectable non-small cell lung cancer
16 October 2023 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neo-adjuvant treatment, and with continuation ...
Posted by Michael Wonder on 14 Oct 2023
US FDA approves Opdivo (nivolumab) as adjuvant treatment for eligible patients with completely resected stage IIB or stage IIC melanoma
13 October 2023 - In the Phase 3 CheckMate-76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to ...
Posted by Michael Wonder on 13 Oct 2023
US FDA approves Pfizer’s Velspity for adults with moderately to severely active ulcerative colitis
13 October 2023 - Approval of oral, once daily Velsipity based on favourable safety and efficacy data from the ELEVATE ...