GSK plc announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOTEN6/GOG3031/NSGO phase III… read more.
Astellas Pharma Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Xtandi (enzalutamide)… read more.
Takeda announced that the FDA has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute… read more.
Sobi announced positive results from the AVA-PED-301 study (NCT04516967), evaluating the efficacy and safety of avatrombopag (Doptelet) for the treatment of paediatric patients with immune thrombocytopenia (ITP) of… read more.
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing… 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 Jubbonti, intended for the… read more.
Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple… read more.
Bristol Myers Squibb announced the Phase III CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who… read more.
CSL Vifor announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of… read more.
– Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, announced the FDA has… read more.
Johnson & Johnson announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommends Carvykti (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple… read more.
NovaBay Pharmaceuticals, Inc. and Eyenovia, Inc. announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S. Under the agreement, NovaBay… read more.
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