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New three-year data demonstrates sustained clinical benefits and established safety profile of Ingrezza (valbenazine) capsules for Huntington’s disease chorea – Neurocrine Biosciences

Written by | 10 Oct 2025

Neurocrine Biosciences, Inc. presented new data from the open-label KINECT-HD2 study demonstrating an established long-term safety profile, tolerability and sustained improvements in chorea severity through three years of… read more.

FDA Approves Zoryve (roflumilast) cream 0.05% for the teatment of aopic dermatitis in children aged 2 to 5 – Arcutis Biotherapeutics

Written by | 9 Oct 2025

Arcutis Biotherapeutics, Inc. announced that the FDA has approved the supplemental new drug application (sNDA) for Zoryve  (roflumilast) cream 0.05% for the topical treatment of mild to moderate… read more.

Camurus announces approval of Oczyesa (octreotide SC) for the treatment of acromegaly in the UK

Written by | 3 Oct 2025

Camurus  announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa, (octreotide subcutaneous depot), marketing authorization for the maintenance treatment in adult patients with… read more.

Nuvaxovid 2025-2026 Formula now approved in Japan triggering Takeda milestone payment – Novavax

Written by | 2 Oct 2025

Novavax Inc. announced a milestone payment from Takeda has been triggered by regulatory approval in Japan for Novavax’s Covid-19 vaccine Nuvaxovid 2025-2026 Formula (Intramuscular Injection 1 mL) formulated… read more.

European Commission grants approval of Ogsiveo (nirogacestat) for treatment of desmoid tumors – Merck

Written by | 1 Oct 2025

Merck KGaA, announced that the European Commission (EC) granted marketing authorization for Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing… read more.

Eisai launches in-house developed anti-insomnia drug Dayvigo (lemborexant) in China

Written by | 30 Sep 2025

Eisai Co., Ltd. announced that the in-house discovered and developed orexin receptor antagonist Dayvigo (brand name in China: “达卫可®“ generic name: lemborexant) has launched in China for the… read more.

NICE (UK) positive for Tremfya (guselkumab) for previously treated moderately to severely active Crohn’s disease – Johnson & Johnson

Written by | 26 Sep 2025

NICE(UK): Guselkumab can be used as an option for previously treated moderately to severely active Crohn’s disease in adults, when: i) conventional or biological treatment: a) has not… read more.

NICE (UK) positive for Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel for untreated primary advanced or recurrent endometrial cancer – Merck

Written by | 25 Sep 2025

NICE (UK): Pembrolizumab with carboplatin and paclitaxel can be used, within its marketing authorisation, as an option for untreated primary advanced or recurrent endometrial cancer in adults. It… read more.

Datroway (datopotamab deruxtecan) approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer – Daiichi Sankyo

Written by | 24 Sep 2025

Datroway (datopotamab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+… read more.

NICE (UK) positive for Raxone (idebenone) for treating visual impairment in Leber’s hereditary optic neuropathy in people 12 years and over – Chiesi

Written by | 23 Sep 2025

NICE (UK): Idebenone is recommended, within its marketing authorisation, as an option for treating visual impairment in Leber’s hereditary optic neuropathy (LHON) in people 12 years and over…. read more.

NICE (UK) positive for Tremfya (guselkumab) for treating moderately to severely active ulcerative colitis – Johnson & Johnson

Written by | 22 Sep 2025

NICE (UK): Guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when: i) a conventional treatment, biological treatment or Janus… read more.

NICE (UK) negative for Imdylltra (tarlatamab) for extensive-stage small-cell lung cancer after 2 or more treatments – Amgen

Written by | 21 Sep 2025

NICE (UK): Tarlatamab should not be used to treat extensive-stage small-cell lung cancer in adults whose cancer has progressed after 2 or more lines of treatment, including platinum-based… read more.

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