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FDA approves Papzimeos (zopapogene imadenovec) for the treatment of adults with recurrent respiratory papillomatosis – Precigen

Written by | 24 Aug 2025

Precigen, Inc. announced that the FDA has approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeosis the first and only FDA-approved therapy… read more.

Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma – Iovance Biotherapeutics

Written by | 23 Aug 2025

Iovance Biotherapeutics Inc. announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy. Amtagvi is indicated for… read more.

FDA restricts use of gene therapy Skysona (elivaldogene autotemcel) due to blood cancer risk concerns – Bluebird Bio

Written by | 22 Aug 2025

The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell… read more.

Wegovy (semaglutide 2.4 mg) approved in the US for the treatment of MASH – Novo Nordisk

Written by | 21 Aug 2025

Novo Nordisk announced that the FDA has approved an additional indication for Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for treatment of noncirrhotic… read more.

NICE (UK) negative for Opzelura (ruxolitinib cream) for treating non-segmental vitiligo in people 12 years and over – Incyte

Written by | 20 Aug 2025

NICE (UK): Ruxolitinib cream is not recommended, within its marketing authorisation, for treating non-segmental vitiligo with facial involvement in people 12 years and over. This recommendation is not intended… read more.

In-licensing announced of a novel clinical phase III-ready Exblifep, an oral antibiotic, ceftibuten-ledaborbactam etzadroxil to treat urinary tract infections – Basilea

Written by | 19 Aug 2025

Basilea Pharmaceutica announced that it has entered into an exclusive license agreement with Venatorx Pharmaceuticals Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil (Exblifep), a clinical phase… read more.

Houston’s Michael E. DeBakey VA Medical Center is among the First VA hospitals to administer Anktiva to bladder cancer patients – ImmunityBio

Written by | 18 Aug 2025

ImmunityBio Inc. announced the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center in Houston recently became the first VA hos Anktiva  (nogapendekin alfa inbakicept-pmln)ital in the… read more.

Lambert Eaton myasthenic syndrome antibody testing and treatment recommendations added to NCCN Clinical Practice Guidelines for small cell lung cancer – Catalyst Pharmaceuticals

Written by | 17 Aug 2025

Catalyst Pharmaceuticals, Inc. announced the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Small Cell Lung Cancer (SCLC) now include new additions involving Lambert Eaton… read more.

Positive topline results from landmark ASPEN study of brensocatib in patients with bronchiectasis – Insmed

Written by | 16 Aug 2025

Insmed announced positive topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase III study to assess the efficacy, safety, and tolerability of brensocatib in patients… read more.

FDA grants accelerated approval to Hernexeos as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC – Boehringer

Written by | 15 Aug 2025

Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved by the FDA. The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small… read more.

Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near-zero Global Warming Potential – AstraZeneca

Written by | 14 Aug 2025

AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has now been approved for use in the… read more.

Avacincaptad pegol is submitted to MHLW (Japan) for the treatment of geographic atrophy secondary to AMD – Astellas

Written by | 13 Aug 2025

Astellas announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol intravitreal solution (ACP),… read more.

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