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FDA accepts for review supplemental biologics license application for self-administration of FluMist Quadrivalent – AstraZeneca

Written by | 30 Oct 2023

Potential to be the first and only self-administered flu vaccine ; AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist… read more.

Landmark 5-year monarchE outcome data demonstrate Verzenio (abemaciclib)’s long-term impact on cancer recurrence in high-risk early breast cancer – Eli Lilly

Written by | 29 Oct 2023

Eli Lilly and Company announced five-year outcomes from a pre-planned analysis of the Phase III monarchE study evaluating two years of adjuvant Verzenio (abemaciclib) in combination with endocrine… read more.

Late-breaking data showcase the benefits of Abbott’s minimally invasive devices for people with leaky heart valves

Written by | 28 Oct 2023

Abbott announced data from late-breaking presentations showing the impact of its minimally invasive heart devices in treating mitral and tricuspid valve disease . Data include findings from the… read more.

European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin Lymphoma in combination with AVD chemotherapy – Takeda

Written by | 27 Oct 2023

Takeda announced that the European Commission (EC) approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage… read more.

Health Canada approves Myfembree to manage moderate to severe pain associated with endometriosis – Sumitomo Pharma Canada + Pfizer Canada

Written by | 26 Oct 2023

Sumitomo Pharma Canada, Inc. and Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for Myfembree (Relugolix, estradiol and norethindrone acetate tablets) for the… read more.

FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of patients 12 year and older – Bausch Health Companies

Written by | 25 Oct 2023

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide)… read more.

FDA approves Voxzogo (vosoritide) for children under 5 years with achondroplasia – BioMarin

Written by | 24 Oct 2023

BioMarin Pharmaceutical Inc. announced that the FDA has approved the supplemental New Drug Application (sNDA) for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia with… read more.

CHMP positive for Vezoa (fezolinetant) to treat vasomotor symptoms associated with menopause – Astellas Pharma

Written by | 23 Oct 2023

Astellas Pharma Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to… read more.

FDA approves Cosentyx as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases – Novartis

Written by | 22 Oct 2023

Novartis,, announced that the FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic… read more.

Spravato (esketamine) demonstrates superior efficacy compared to quetiapine extended-release in treatment-resistant major depressive disorder – Johnson & Johnson

Written by | 21 Oct 2023

An open-label, international study published in the New England Journal of Medicine found that patients receiving Spravato (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times… read more.

Imlifidase demonstrated 90% patient survival and 82% graft survival at five years in extended pooled analysis with data from 17-HMedIdeS-14 study in kidney transplant patients – Hansa Biopharma

Written by | 20 Oct 2023

Hansa Biopharma announced results from an extended pooled analysis using data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant… read more.

CHMP positive for Elucirem (gadopiclenol) in the European Union (EU) for use in adults and children aged 2 years and over for MRI with contrast enhancement – Guerbet S.A + Bracco

Written by | 19 Oct 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the granting of a marketing authorisation for… read more.

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