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FDA approval of Simplera continuous glucose monitor (CGM) and global partnership with Abbott – Medtronic

Written by | 13 Aug 2024

Medtronic plc announced the FDA approval for its Simplera continuous glucose monitor (CGM) — the company’s first disposable, all-in-one CGM that’s half the size of previous Medtronic CGMs…. read more.

Seres Therapeutics announces signing of Vowst asset purchase agreement with Nestlé Health Science

Written by | 12 Aug 2024

Seres Therapeutics, Inc. announced that it signed an agreement with Société des Produits Nestlé S.A (“Nestlé”) for the sale of its Vowst business to Nestlé Health Science. Upon… read more.

FDA approval for Inspire V therapy system to treat obstructive sleep disorder – Inspire Medical Systems

Written by | 11 Aug 2024

Inspire Medical Systems, In a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the… read more.

FDA approval of neffy (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis – ARS Pharmaceuticals

Written by | 10 Aug 2024

ARS Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced… read more.

Asciminib receives FDA priority review for newly diagnosed Ph+ CP-CML – Novartis

Written by | 9 Aug 2024

The FDA has granted priority review to asciminib (Scemblix) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase (CP-CML)…. read more.

European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab) – UCB

Written by | 8 Aug 2024

UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and… read more.

FDA advisers call for review of perioperative lung cancer trials – AstraZeneca

Written by | 7 Aug 2024

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a review of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment… read more.

Vir Biotechnology to withdraw from infectious diseases research

Written by | 6 Aug 2024

Vir Biotechnology is cutting one-quarter of its workforce in a move away from infectious disease research. The company, which rose to prominence with its coronavirus antibody work in… read more.

CHMP recommends Yuvanci (macitentan + tadalafil) to treat pulmonary arterial hypertension – Johnson & Johnson

Written by | 5 Aug 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yuvanci, intended for the… read more.

Positive CHMP opinion for including Mpox real-world effectiveness data in European Marketing Authorization for smallpox and Mpox vaccine – Bavarian Nordic

Written by | 4 Aug 2024

Bavarian Nordic A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a type II… read more.

FDA Advisory Committee reviewed Imfinzi (durvalumab) for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results – AstraZeneca

Written by | 3 Aug 2024

The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.

European Commission approves Vabysmo (faricimab) for treatment of retinal vein occlusion – Roche

Written by | 2 Aug 2024

Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch… read more.

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