Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.
Alexion Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved ULTOMIRIS (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) for adult and pediatric (one month of age and older) patients.
AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat people at high risk of developing influenza-related complications.
Bayer and Janssen Research & Development have secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) to prevent blood clots in acutely ill medical patients.
Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its Reyvow (lasmiditan) for the acute treatment of migraine.
Novartis' Beovu (brolucizumab) injection has secured approval from the US Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD).
Pfenex has secured approval for PF708, a biosimilar of Forteo (teriparatide injection), from the US Food and Drug Administration (FDA) for the treatment of osteoporosis in certain patients who are highly prone to fracture.
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).
Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for HIV pre-exposure prophylaxis (PrEP) indication of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).
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