Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk… read more.
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.
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.
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.
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.
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.
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.
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 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 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.
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 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.
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