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New data shows early addition of twice-yearly Leqvio (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting – Novartis

Written by | 12 Apr 2024

Novartis announced new data demonstrating the early addition of twice-yearly Leqvio (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density… read more.

Imfinzi (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial – AstraZeneca

Written by | 11 Apr 2024

Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall… read more.

FDA clearance of Rejoyn the first prescription digital therapeutic authorized in the U.S. for the treatment of major depressive disorder – Otsuka

Written by | 10 Apr 2024

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the FDA has cleared Rejoyn (developed as CT-152), the first prescription digital therapeutic authorized in the U.S. for… read more.

FDA approval for Fanapt (iloperidone) tablets to treat manic or mixed episodes associated with bipolar I disorder in adults – Vanda Pharma

Written by | 9 Apr 2024

Vanda Pharmaceuticals Inc announced that the FDA has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults…. read more.

Sugemalimab approved in China as first-line treatment for gastric cancer – CStone Pharmaceuticals

Written by | 8 Apr 2024

CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has approved the supplemental biologics license application (sBLA) for sugemalimab (Cejemly) in combination with fluoropyrimidine- and… read more.

Truqap (capivasertib) + Faslodex (fulvestrant) approved in Japan for patients with advanced HR-positive breast cancer – AstraZeneca

Written by | 7 Apr 2024

AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone… read more.

Harris Poll survey finds people receiving treatment for CIDP are interested in exploring more convenient treatment options – CSL Behring

Written by | 6 Apr 2024

CSL Behring, announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment… read more.

Health Canada approves Bimzelx (bimekizumab injection) for the treatment of adults with axial spondyloarthritis (axSpA) – UCB

Written by | 5 Apr 2024

UCB Canada Inc. is pleased to announce that Bimzelx (bimekizumab injection) has received authorization from Health Canada for two new indications. On February 23, 2024, BImzelx was approved… read more.

FDA approves Edurant Ped (rilpivirine) for certain pediatric patients Living with HIV-1 – Johnson & Johnson

Written by | 4 Apr 2024

Johnson & Johnson announced that the FDA has approved Edurant Ped (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with… read more.

MHRA (UK) extends indication of Mavenclad (cladribine tablets) for relapsing forms of multiple sclerosis – Merck KGaA

Written by | 3 Apr 2024

Mavenclad (cladribine tablets) from Merck KGaA, is now indicated for the treatment of adult patients with relapsing forms of Multiple Sclerosis (MS) with active disease as defined by… read more.

MHLW (Japan) approves Beyfortus (nirsevimab) in Japan for the prevention of RSV disease in infants – AstraZeneca

Written by | 2 Apr 2024

AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in Japan for the prophylaxis of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus… read more.

FDA grants full approval for Elahere (mirvetuximab soravtansine-gynx) for certain ovarian cancer patients – Abbvie

Written by | 1 Apr 2024

AbbVie announced that the FDA has granted full approval for Elahere (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary… read more.

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