Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Ajovy (fremanezumab-vfrm) to expand the… read more.
NICE (UK): burosumab is recommended, within its marketing authorisation, for treating X‑linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over, and in… read more.
Monogram Technologies Inc. an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, announced that the FDA has granted 510(k) clearance for… read more.
The first asthma patient has commenced treatment with Relovair (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the Phase III clinical development programme with… read more.
Pfizer Inc. announced that the European Commission (EC) has issued a decision amending the marketing authorization for Abrysvo the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF)… read more.
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the… read more.
Novo Nordisk presented the full results from STRIDE, a phase III peripheral artery disease (PAD) outcomes trial investigating the effects of once-weekly injectable Ozempic (semaglutide 1.0 mg) in… read more.
EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults with obesity or overweight. The review… read more.
The FDA announced the approval of Omlyclo (omalizumab-igec) as the first biosimilar to reference Xolair (omalizumab). The biosimilar was also approved with interchangeability status and is the first… read more.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has… read more.
Santen Pharmaceutical Co., Ltd. announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Ryjunea (:STN 1012701). Ryjunea is a… read more.
Allurion Technologies, Inc. announced initial results on the combination of the Allurion Program with low-dose GLP-1 therapy to optimize muscle mass and GLP-1 adherence. 52 patients treated with… read more.
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