Mallinckrodt Plc and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate Of Health… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto, intended for the… read more.
Bristol Myers Squibb and bluebird bio, Inc. announced the submission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational… read more.
Seqirus, a global leader in influenza prevention, announced that its adjuvanted quadrivalent influenza vaccine (aQIV) – launching as Fluad Tetra – has received a positive opinion from the… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Pretomanid FGK, intended… read more.
Horizon Therapeutics announced new pooled efficacy data from the Phase II and III clinical trials of Tepezza (teprotumumab-trbw) showing that the recently approved medicine effectively reduces proptosis (eye… read more.
The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), from Orion Corporation and Bayer. The approval… read more.
Results from two subgroup analyses of the Phase IV independent TWILIGHT trial funded by AstraZeneca showed Brilinta (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding over 12… read more.
Imfinzi (durvalumab) from AstraZeneca has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care… read more.
Pharming has announced the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an… read more.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab). The CHMP recommends Sarclisa in combination with pomalidomide… read more.
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX 14. China-based… read more.
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