AbbVie announced the final analysis of the confirmatory Phase III MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive… read more.
Eli Lilly announced results from the Phase III BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor in adult patients with chronic lymphocytic leukemia or… read more.
Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase III BREAKWATER study of Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6… read more.
Regeneron Pharmaceuticals, Inc. announced positive results from the Phase III C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo (cemiplimab) led to a statistically significant and… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Calquence…. read more.
The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) from Sanofi for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus…. read more.
Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the… read more.
GSK plc announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with… read more.
AIM ImmunoTech Inc. offered commentary on a new article in the Journal of General Internal Medicine linking COVID-19 to increased risk of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”). The… read more.
scPharmaceuticals Inc., announced that the FDA has approved the supplemental New Drug Application (sNDA) for Furoscix to expand the indication to include treatment of edema in patients with… read more.
Roche announced new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provide further evidence supporting the… read more.
The FDA has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease. The decision follows a supplemental application from Eisai, which is codeveloping Leqembi… read more.
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