Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking approval of Spravato (esketamine) CIII nasal spray as a monotherapy for… read more.
Indivior has discontinued sales and marketing for its schizophrenia drug Perseris. This last decision, prompted by increased payor management impacts, is expected to make the product financially unviable… read more.
The biologics license application (BLA) seeking the approval of tabelecleucel (tab-cel) monotherapy for the treatment of adult and pediatric patients who are at least 2 years of age… read more.
The addition of durvalumab (Imfinzi) to gemcitabine and cisplatin demonstrated a sustained overall survival (OS) benefit vs chemotherapy alone in patients with unresectable, locally advanced or metastatic biliary… read more.
Phathom Pharmaceuticals, Inc. announced the FDA has approved Voquezna (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults…. read more.
Zai Lab Limited and argenx announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg… read more.
Sobi announced the publication of full results from the Phase III XTEND-Kids study in The New England Journal of Medicine (NEJM) confirming the safety and efficacy profile of… read more.
Roche announced four-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab) was well tolerated in people with diabetic macular edema… read more.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s subcutaneous version of Ocrevus (ocrelizumab subcutaneous ) to treat patients with relapsing and primary progressive… read more.
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.( radiological progression-free survival). Darolutamide… read more.
Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of… read more.
Novo Nordisk announced that the FDA has issued a Complete Response Letter covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus…. read more.
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