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Sobi announces positive results from phase III study of Doptelet (avatrombopag) for treatment of children and adolescents with immune thrombocytopenia

Written by | 28 Mar 2024

Sobi announced positive results from the AVA-PED-301 study (NCT04516967), evaluating the efficacy and safety of avatrombopag (Doptelet) for the treatment of paediatric patients with immune thrombocytopenia (ITP) of… read more.

Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria – Novartis

Written by | 27 Mar 2024

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing… read more.

CHMP positive for Jubbonti a denosumab (Prolia) biosimilar – Sandoz

Written by | 26 Mar 2024

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

Abecma (idecabtagene vicleucel) becomes first CAR T Cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma – BMS

Written by | 25 Mar 2024

Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple… read more.

CheckMate-9DW trial evaluating Opdivo (nivolumab) + Yervoy (ipilimumab) meets primary endpoint of overall survival for the first-line treatment of advanced hepatocellular carcinoma – BMS

Written by | 24 Mar 2024

Bristol Myers Squibb announced the Phase III CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who… read more.

Ferinject (ferric carboxymaltose) approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure – CSL Vifor

Written by | 23 Mar 2024

CSL Vifor announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of… read more.

FDA approval for Lenmeldy (atidarsagene autotemcel), to treat early-onset metachromatic leukodystrophy – Orchard Therapeutics

Written by | 22 Mar 2024

– Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the FDA has… read more.

FDA Oncologic Drugs Advisory Committee recommends Carvykti (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma – Johnson & Johnson

Written by | 21 Mar 2024

Johnson & Johnson announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommends Carvykti (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple… read more.

Novabay Pharmaceuticals and Eyenovia collaborate to co-promote ophthalmic products in the USA

Written by | 20 Mar 2024

NovaBay Pharmaceuticals, Inc. and Eyenovia, Inc. announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S. Under the agreement, NovaBay… read more.

FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy – BeiGene

Written by | 19 Mar 2024

BeiGene, Ltd. announced that the FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after… read more.

Santhera’s partner Catalyst Pharmaceuticals launches Agamree (vamorolone) in the United States to treat Duchenne muscular dystrophy

Written by | 18 Mar 2024

Santhera Pharmaceuticals is pleased to note the launch of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States by Catalyst Pharmaceuticals, Inc. the… read more.

FDA approves Opdivo (nivolumab), plus cisplatin and gemcitabine, for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 17 Mar 2024

Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial… read more.

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