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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.

Sotyktu (deucravacitinib) long-term data demonstrate durable efficacy and consistent safety for up to three years in moderate-to-severe plaque psoriasis – BMS

Written by | 18 Oct 2023

Bristol Myers Squibb announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. At Week… read more.

Update on ConfIdeS phase III trial of imlifidase in highly sensitized kidney transplant patients – Hansa Biopharma

Written by | 17 Oct 2023

Hansa Biopharma announced randomization for the US ConfIdeS trial is expected to conclude in mid-2024. The ConfIdeS trial is an open-label, controlled, randomized Phase III trial evaluating 12-month… read more.

Keytruda (pembrolizumab) met a primary endpoint of disease-free survival in certain patients with muscle-invasive urothelial carcinoma after surgery – Merck Inc

Written by | 16 Oct 2023

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating Keytruda, Merck’s anti-PD-1 therapy, met one… read more.

FDA approves Zoryve (roflumilast) cream 0.3% for treatment of psoriasis in children ages 6 to 11- Arcutis Biotherapeutics

Written by | 15 Oct 2023

Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) to expand the indication of Zoryve (roflumilast) cream 0.3% for the topical treatment of… read more.

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