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FDA approves Selarsdi (ustekinumab-biosimilar) to treat plaque psoriasis and active psoriatic arthritis – Teva + Alvotech

Written by | 24 Apr 2024

Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to… read more.

FDA approves Alecensa (alectinib) as the first adjuvant treatment for people with ALK-positive early-stage lung cancer – Genentech/Roche

Written by | 23 Apr 2024

Roche announced that the FDA has approved Alecensa (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours… read more.

Health Canada approves new indication for Prevymis (letermovir) for prevention of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients – Merck

Written by | 22 Apr 2024

Merck Inc. known as MSD outside of the United States and Canada, announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis of… read more.

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.

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