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FDA approves denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) – Fresenius Kabi

Written by | 14 Apr 2025

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.

Ozempic shown to improve walking distance and quality of life in adults with type 2 diabetes and peripheral artery disease at ACC 2025 – Novo Nordisk

Written by | 13 Apr 2025

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 concludes review of weight management medicine Mysimba (naltrexone / bupropion) – Currax Pharmaceuticals

Written by | 12 Apr 2025

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.

FDA approval for Omlyclo (omalizumab-igec) as the first biosimilar to reference Xolair (omalizumab) – Celltrion

Written by | 11 Apr 2025

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.

EU approves Imfinzi (durvalumab) as first and only immunotherapy for limited-stage small cell lung cancer – AstraZeneca

Written by | 10 Apr 2025

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 receives positive CHMP opinion in Europe for Ryjunea for slowing the progression of paediatric myopia

Written by | 9 Apr 2025

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.

Initial results announced on the combination of the Allurion balloon with low-dose GLP-1 therapy to optimize muscle mass and GLP-1 adherence – Allurion Technologies

Written by | 8 Apr 2025

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.

CHMP positive for a label extension for Ixchiq a single-dose vaccine for the prevention of disease caused by the chikungunya virus – Valneva SE

Written by | 7 Apr 2025

Valneva SE, a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion… read more.

CHMP postive for Deqsiga intended for replacement therapy in people with primary or secondary immunodeficiencies and immunomodulation – Takeda

Written by | 6 Apr 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deqsiga, intended for replacement therapy in people… read more.

Olumiant (baricitinib) delivered high rates of hair regrowth for adolescents with severe alopecia areata in phase III BRAVE-AA-PEDS study – Eli Lilly

Written by | 5 Apr 2025

Late-breaking results from Eli Lilly and Company and Incyte found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4… read more.

CE Mark approved in Europe for the Volt PFA system to treat patients with atrial fibrillation – Abbott

Written by | 4 Apr 2025

Abbott announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has… read more.

FDA approves label changes for Sublocade (buprenorphine extended-release) including rapid initiation and alternative injection sites – Indivior

Written by | 3 Apr 2025

Indivior PLC announced that the FDA has approved label changes for Sublocade (buprenorphine extended-release ) including a rapid initiation protocol and alternative injection sites, marking a significant advancement… read more.

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