According to information published on the European Medicines Agency (EMA) website, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of… read more.
Johnson & Johnson announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI (teclistamab-cqyv) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in… read more.
Eli Lilly and Company announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to… read more.
Bristol Myers Squibb announced first time presentation of results from the prespecified analysis of the pivotal Phase 3 EXCALIBER-RRMM trial (NCT04975997) evaluating ZENBEXUS (iberdomide) in combination with daratumumab… read more.
Abbott announced FDA approval for updates to the CardioMEMS HF System that enable new patient-facing capabilities through the CardioGuide HF App. For the first time, care teams can… read more.
AnaptysBio, Inc. a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, announced that GSK has received U.S…. read more.
Johnson & Johnson announced the U.S. launch of its Shockwave C2 Aero Fly Coronary IVL Catheter designed to treat a broad range of calcified coronary artery lesions in… read more.
Valneva SE announced that, following a further benefit-risk assessment of Ixchiq for travelers by the United Kingdom’s (UK) Commission on Human Medicines (CHM), the UK marketing authorization for… read more.
Nirogacestat can be used, within its marketing authorisation, as an option to treat progressing desmoid tumours that need systemic treatment in adults. Nirogacestat can only be used if… read more.
Scholar Rock announced it has resubmitted the Marketing Authorisation Application (MAA) for apitegromab for the treatment of children and adults with spinal muscular atrophy (SMA) to the European… read more.
Biofrontera announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, in… read more.
Atara Biotherapeutics, Inc. announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the FDA of the Biologics License Application (BLA) resubmission for tabelecleucel, with… read more.
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