The results of a clinical trial have shown that a drug commonly used for patients with bleeding disorders has the potential to be used to lessen the side… read more.
Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira… read more.
Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic… read more.
Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of… read more.
UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific… read more.
AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with… read more.
The FDA recently approved the Janus kinase (JAK) inhibitor ritlecitinib (Litfulo) for adults and adolescents with severe alopecia areata. It is, so far, the only treatment approved by the FDA… read more.
Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study. The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera… read more.
Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia…. 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 approval of atogepant for the… read more.
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