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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.

Positive RUBY phase III data show potential for Jemperli (dostarlimab) combinations in more patients with primary advanced or recurrent endometrial cancer – GSK

Written by | 31 Mar 2024

GSK plc announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOTEN6/GOG3031/NSGO phase III… read more.

Positive CHMP opinion for Xtandi (enzaltamide) in additional recurrent early prostate cancer treatment setting – Astellas

Written by | 30 Mar 2024

Astellas Pharma Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Xtandi (enzalutamide)… read more.

FDA approval of supplemental NDA for for Iclusig (ponatinb) in adult patients with newly diagnosed Ph+ ALL – Takeda

Written by | 29 Mar 2024

Takeda announced that the FDA has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute… read more.

Sobi announces positive results from phase III study of Doptelet (avatrombopag) for treatment of children and adolescents with immune thrombocytopenia

Written by | 28 Mar 2024

Sobi announced positive results from the AVA-PED-301 study (NCT04516967), evaluating the efficacy and safety of avatrombopag (Doptelet) for the treatment of paediatric patients with immune thrombocytopenia (ITP) of… read more.

Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria – Novartis

Written by | 27 Mar 2024

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing… read more.

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