US FDA approves AstraZeneca’s Tagrisso for patients with …
WEB3 days ago — AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential ...
PTC Therapeutics’ PTC518 Huntington's disease programme …
WEB1 day ago — Warren, New Jersey. Saturday, September 28, 2024, 17:00 Hrs [IST] PTC Therapeutics announced that the FDA has granted Fast Track designation to the PTC518 programme for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need. "The granting of Fast Track designation to the ...
US FDA approves IntraBio’s Aqneursa to treat Niemann-pick …
WEB2 days ago — IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, announced that the US Food and Drug Administration (FDA) has approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and paediatric patients weighing =15 kg.
US FDA approves anti-CD38 therapy, Sarclisa in combo with …
WEB6 days ago — The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant ...
US FDA grants Emergency Use Authorization to Novavax 2024 …
WEBSep 2, 2024 — Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for active immunization to ...
Innate Pharma gets US FDA clearance to begin phase 1 study of …
WEB5 days ago — Innate Pharma SA a global, clinical-stage biotechnology company developing immunotherapies for cancer patients, announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a phase 1 clinical study of IPH4502, its novel and ...
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Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
WEBFriday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
US FDA approves Illumina cancer biomarker test, TruSight …
WEBAug 29, 2024 — Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications. This single test interrogates ...
AstraZeneca to acquire clinical-stage biopharma company, Fusion …
WEBMar 20, 2024 — AstraZeneca to acquire clinical-stage biopharma company, Fusion Pharma for $2 billion: Cambridge, UK Wednesday, March 20, 2024, 11:00 Hrs [IST] AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs).