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Galapagos to review future of Jyseleca

Written by | 8 Aug 2023

Galapagos revealed that it is weighing up all options for its only approved product, the JAK inhibitor Jyseleca. Galapagos has disclosed its financials for the first half 2023… read more.

European Commission approves Lonsurf in combination with bevacizumab for the third-line treatment of metastatic colorectal cancer – Servier + Taiho

Written by | 7 Aug 2023

Taiho Pharmaceutical announced that its partner Servier, has won European regulatory approval for Lonsurf (trifluridine + tipiracil) in combination with bevacizumab for the third-line treatment of metastatic colorectal… read more.

Livmarli receives Health Canada authorization for Alagille syndrome – Mirum Pharmaceuticals

Written by | 6 Aug 2023

Health Canada has authorized the use of maralixibat oral solution (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS), as recently announced by Mirum… read more.

Jardiance approved in the EU for the treatment of adults with chronic kidney disease – Boehringer + Eli Lilly

Written by | 5 Aug 2023

The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company have announced. The approval… read more.

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

Written by | 4 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant… read more.

Jemperli + chemotherapy approved by the FDA as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer – GSK

Written by | 3 Aug 2023

GSK plc announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult… read more.

European Commission approves Trodelvy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer patients who have received endocrine-based therapy – Gilead Sciences

Written by | 2 Aug 2023

Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor… read more.

Vyalev a continuous subcutaneousinfusion for Parkinson’s disease is now launched in Japan – AbbVie

Written by | 1 Aug 2023

AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26. This is the first Parkinson’s drug in the country… read more.

CHMP recommends Abrysvo the first RSV vaccine to protect infants up to 6 months of age and older adults – Pfizer

Written by | 31 Jul 2023

The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is… read more.

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Written by | 30 Jul 2023

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest… read more.

FDA approves Ycanth to treat molluscum contagiosum – Verrica Pharma

Written by | 29 Jul 2023

Verrica Pharmaceuticals Inc. ,a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, announced FDA approval of Ycanth (cantharidin) topical solution for the treatment of molluscum… read more.

Long term phase III data published in Arthritis & Rheumatology shows Lupkynis preserved kidney function up to three years in lupus nephritis patients with no new or unexpected adverse events – Aurinia Pharma

Written by | 28 Jul 2023

Aurinia Pharmaceuticals Inc. announced that full results from the Phase III, double-blind, placebo-controlled AURORA 2 extension study were published online in Arthritis & Rheumatology, the official peer-reviewed journal… read more.

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