Sandoz, the global leader in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Wyost (C) and Jubbonti (denosumab), the first and… read more.
Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to Humira (adalimumab), in the… read more.
Bristol Myers Squibb announced the FDA has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of… read more.
-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.
Zai Lab Limited announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for Augtyro (repotrectinib) for the treatment of adult… read more.
UCB, announced that The Lancet has published results from the Phase III BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab, an… read more.
Amgen announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after… read more.
Ascendis Pharma A/S announced that the FDA notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon… read more.
Bristol Myers Squibb announced new four-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. After four… read more.
Eisai announces approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (generic name: perampanel hydrate) for adjunctive treatment of primary generalized tonic/clonic… read more.
Shionogi & Co., Ltd. announced that its pivotal, double-blind, randomized, placebo-controlled global Phase III study (SCORPIO-HR) did not meet its primary endpoint of a statistically significant reduction in… read more.
Dynavax Technologies Corporation provided a regulatory update for the Company’s supplemental Biologics License Application (sBLA) to include a four-dose Heplisav- B vaccine [Hepatitis B Vaccine (Recombinant),Adjuvanted] regimen for… read more.
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