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FDA grants clearance for first-ever digital bone marrow aspirate application – Scopio Labs

Written by | 21 Apr 2024

Scopio Labs, developer of Full-Field Digital Cell Morphology imaging and analysis platforms and a recognized leader in digital morphology, announced that it has been granted De Novo clearance… read more.

Kesimpta (ofatumumab) six-year efficacy data show substantial benefits in recently diagnosed treatment-naïve people with relapsing multiple sclerosis – Novartis

Written by | 20 Apr 2024

Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability… read more.

Imfinzi (durvalumab) plus chemotherapy doubled overall survival rate at three years for patients with advanced biliary tract cancer in TOPAZ-1 phase III trial – AstraZeneca

Written by | 19 Apr 2024

Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at… read more.

FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV – ViiV Healthcare

Written by | 18 Apr 2024

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1… read more.

Late-breaking data presented at AAN supporting long-term safety and efficacy of atogepant (Qulipta) for preventive treatment of migraine – AbbVie

Written by | 17 Apr 2024

AbbVie announced an interim analysis of an ongoing Phase III, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine… read more.

Latest real-world evidence presented at WCO-IOF-ESCEO assesses how Evenity (romosozumab) can help to close the treatment gap in osteoporosis – UCB

Written by | 16 Apr 2024

UCB, announced key findings from the first retrospective patient cohort study in Denmark to observe the characteristics of patients selected for romosozumab treatment in routine clinical practice. The… read more.

European Commission approves Keytruda (pembrolizumab) + chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults – Merck

Written by | 15 Apr 2024

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-containing… read more.

Positive top-line results from phase III study of Abrysvo in adults aged 18 to 59 at increased risk for RSV disease – Pfizer

Written by | 14 Apr 2024

Pfizer Inc. announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase III clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of… read more.

Risvan (risperidone ISM) receives FDA approval as a treatment for schizophrenia – Laboratorios Farmacéuticos Rovi, S.A

Written by | 13 Apr 2024

Laboratorios Farmacéuticos Rovi, S.A. has announced that the FDA has authorised the marketing of Risvan (risperidone ISM ) for the treatment of schizophrenia in adults. Risperidone ISM is… read more.

New data shows early addition of twice-yearly Leqvio (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting – Novartis

Written by | 12 Apr 2024

Novartis announced new data demonstrating the early addition of twice-yearly Leqvio (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density… read more.

Imfinzi (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial – AstraZeneca

Written by | 11 Apr 2024

Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall… read more.

FDA clearance of Rejoyn the first prescription digital therapeutic authorized in the U.S. for the treatment of major depressive disorder – Otsuka

Written by | 10 Apr 2024

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the FDA has cleared Rejoyn (developed as CT-152), the first prescription digital therapeutic authorized in the U.S. for… read more.

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