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Supplemental New Drug Application submitted for Zoryve (roflumilast) cream 0.3% to expand indication for treatment of plaque psoriasis in children ages 2 to 5 – Arcutis Biotherapeutics

Written by | 7 Sep 2025

Arcutis Biotherapeutics Inc. announced the submission of a supplemental New Drug Application (sNDA) to the FDA to expand the indication of Zoryve (roflumilast) ) cream 0.3% for the… read more.

Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide in real-world study of people with obesity and cardiovascular disease – Novo Nordisk

Written by | 6 Sep 2025

Novo Nordisk presented data from the STEER real-world study of evidence gathered from actual patient experiences at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain…. read more.

NICE (UK) positive for tirzepatide for managing overweight and obesity – Eli Lilly

Written by | 5 Sep 2025

NICE (UK): Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity in adults, only if they have: i)… read more.

FDA approves REMS modification for Filspari (sparsentan) in IgA nephropathy – Travere Theraputics

Written by | 4 Sep 2025

Travere Therapeutics, Inc., announced that the FDA has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for… read more.

Tryvio (aprocitentan) now included in ACC/AHA clinical practice guidelines for the treatment of hypertension – Idorsia

Written by | 3 Sep 2025

Idorsia Ltd  announced that its novel dual endothelin receptor antagonist (ERA), Tryvio (aprocitentan), has been included in the new comprehensive clinical practice guidelines for the management of systemic… read more.

NICE (UK) positive for Imfinzi (durvalumab) with Imjudo (tremelimumab) for untreated advanced or unresectable hepatocellular carcinoma – AstraZeneca

Written by | 2 Sep 2025

NICE(UK): Durvalumab with tremelimumab can be used, within its marketing authorisation, as an option for untreated advanced or unresectable hepatocellular carcinoma (HCC) in adults. Durvalumab with tremelimumab can… read more.

SERENITY At-Home phase III trial evaluating BXCL 501, sublingual film formulation of dexmedetomidine, met its endpoint as an acute treatment for bipolar/schizophrenia agitation – BioXcel Therapeutics

Written by | 1 Sep 2025

-BioXcel Therapeutics, Inc announced that the SERENITY At-Home Pivotal Phase III trial evaluating the safety of BXCL 501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an… read more.

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.

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.

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.

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