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Orlynvah (sulopenem etzadroxil and probenecid), the first and only oral penem antibiotic launched in the U.S. – Iterum Therapeutics

Written by | 31 Aug 2025

Iterum Therapeutics plc announced the U.S. launch of Orlynvah (sulopenem etzadroxil and probenecid) oral tablets. The FDA had  approved Orlynvah for adult women with uncomplicated urinary tract infections… read more.

European Commission authorises twice-yearly Yeytuo (lenacapavir) for HIV prevention – Gilead Sciences

Written by | 30 Aug 2025

Gilead Sciences Inc. announced that the European Commission (EC) has granted marketing authorization for Yeytuo (lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to… read more.

European Commission approval received for Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis – Madrigal Pharma

Written by | 29 Aug 2025

Madrigal Pharmaceuticals Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to… read more.

Biogen and Stoke Therapeutics to share latest results from zorevunersen studies in Dravet syndrome at IEC 2025

Written by | 28 Aug 2025

Biogen Inc and Stoke Therapeutics Inc, a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, announced presentations of new clinical data… read more.

Dawnzera (donidalorsen) approved in the U.S. as first and only RNA-targeted prophylactic treatment for hereditary angioedema – Ionis Pharmaceuticals

Written by | 28 Aug 2025

Ionis Pharmaceuticals,Inc. announced that the FDA has approved Dawnzera (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age… read more.

European Commission approves tablet formulation of Brukinsa for all approved indications – BeOne Medicines

Written by | 27 Aug 2025

BeOne Medicines Ltd. announced that the European Commission has approved a new film-coated tablet formulation of Brunkinsa (zanubrutinib) for all approved indications. “Developed to meet the real-world needs… read more.

Iovance provides updates on Amtagvi (lifileucel)

Written by | 26 Aug 2025

In its latest (Q2) earnings report, Iovance confirmed plans to reduce its workforce by 19% in a bid to save $100 million in yearly costs due to lower… read more.

Tryvio (aprocitentan) nominated for the 2025 Prix Galien USA “Best Pharmaceutical Product” – Idorsia

Written by | 25 Aug 2025

Idorsia announced that The Galien Foundation, a premier global institution dedicated to honoring innovators in life sciences, has nominated  Tryvio (aprocitentan) in the category of “Best Pharmaceutical Product”… read more.

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.

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