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EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…

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Gedeon Richter

Gedeon Richter Reports the EC Approval of Fylrevy for Hormone Replacement Therapy (HRT) 

Shots:  The EC has approved Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg) across EEA markets  Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women  Preclinical and clinical data show that estetrol (E4) has…

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Bayer

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support

Shots: Bayer launched CanesMeno in the UK to provide menopause support that incl. digital informative resources (CanesMeno Hub) & scientifically-backed products (Hydration & Comfort Gel, Multi-Support, & Night Support). Wider availability in major supermarkets & grocery stores will start from early spring 2025 The hub offers a 3-min. guide, a tracker for personalized insights…

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VIEWPOINTS_Justin Schreiber_2023

Justin Schreiber Discusses the Recently Launched D2C Telehealth Model for Hormone Therapy

Shots:   Justin Schreiber, Chairman, and CEO of, LifeMD, in an illuminating conversation with PharmaShots, discusses the recent partnership with ASCEND Therapeutics    LifeMD, a virtual primary care company, and ASCEND Therapeutics, a leading women's health pharmaceutical company, came together to bring an integrated direct-to-consumer telehealth model to enhance the way women receive care for their menopause…

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