The FDA has granted priority review to asciminib (Scemblix) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase (CP-CML)…. read more.
UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and… read more.
Atrial fibrillation (Afib) is the most common heart rhythm disorder encountered in clinical practice according to Dr. Roopinder Sandhu, MD, MPH, and the leading cause of stroke in… read more.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a review of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment… read more.
Vir Biotechnology is cutting one-quarter of its workforce in a move away from infectious disease research. The company, which rose to prominence with its coronavirus antibody work in… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yuvanci, intended for the… read more.
Bavarian Nordic A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a type II… read more.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.
Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch… read more.
Pfizer Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe… read more.
On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Sun Pharmaceutical Industry announced that the FDA approved Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. Alopecia areata affects around 700,000 people… read more.
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