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Late breaking data for Bimzelx (bimekizumab) from two year phase III studies in moderate to severe hidradentis suppurativa presented at EADV – UCB

Written by | 9 Oct 2024

UCB, announced the first presentation of two-year data from the Phase III studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and… read more.

European Commission approves Otulfi (ustekinumab biosimilar) from Fresenius Kabi

Written by | 8 Oct 2024

Formycon AG and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for Otulfi, a biosimilar to Stelara. The centralized… read more.

CHMP positive opinion for Omicron KP.2-adapted COVID-19 vaccine in the EU – Pfizer + BioNTech

Written by | 7 Oct 2024

Pfizer  and BioNTech SE announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended marketing authorization for the companies’… read more.

Positive CHMP opinion for mirvetuximab soravtansine for the treatment of certain ovarian cancer – AbbVie

Written by | 6 Oct 2024

AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine… read more.

Tepezza (teprotumumab-trbw) receives approval in Japan for the treatment of active thyroid eye disease – Amgen

Written by | 5 Oct 2024

Amgen announced  Tepezza  has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan’s Ministry of Health, Labour and Welfare (MHLW)…. read more.

NICE (UK) positive for Lonsurf (tifluridine–tipiracil) + Avastin (bevacizumab) to treat colorectal cancer – Servier

Written by | 4 Oct 2024

Trifluridine–tipiracil with bevacizumab is NICE  recommended, within its marketing authorisation, for treating metastatic colorectal cancer in adults who have had 2 lines of treatment (including fluoropyrimidine-, oxaliplatin- and irinotecan-based… read more.

FDA approves Cobenfy (xanomeline and trospium chloride), a first-In-class muscarinic agonist for the treatment of schizophrenia in adults – BMS

Written by | 3 Oct 2024

Bristol Myers Squibb announced that the FDA  has approved Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.  Cobenfy represents the first… read more.

Pfizer withdraws all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease

Written by | 2 Oct 2024

Pfizer Inc.  announced  that it is voluntarily withdrawing all lots of Oxbryta voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where… read more.

Medtronic expands AiBLE spine surgery ecosystem with new technologies

Written by | 1 Oct 2024

Medtronic plc  announced at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations. These enhancements are… read more.

NICE (UK) recommends Crysvita (burosumab) to treat X-linked hypophosphatemia in children – Kyowa Kirin

Written by | 30 Sep 2024

Burosumab is  NICE recommended, within its marketing authorisation, for treating X- linked hypophosphatemia (XLH) with radiographic evidence of bone disease in babies, children and young people 1 to… read more.

Bavarian Nordic receives EMA approval of Mpox vaccine for adolescents – Bavarian Nordic

Written by | 29 Sep 2024

Bavarian Nordic A/S announced  that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of a type II variation… read more.

UCB announces the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab

Written by | 28 Sep 2024

UCB, a global biopharmaceutical company, announced the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab, an IL-17A and IL-17F inhibitor…. read more.

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