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.
AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted priority review.
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).
DBV Technologies, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
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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