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.
Genentech, a member of the Roche Group announced that the FDA has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS)… read more.
ALK announced that the FDA has approved ALK’s Odactra tablet for use in young children with house dust mite (HDM) allergy.Odactra is now indicated to treat HDM-induced allergic… read more.
Roche announced that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody programme were presented at the 66th American Society of Hematology (ASH) Annual Meeting &… read more.
Moderna Inc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the… read more.
Galderma announced that the European Commission has approved Nemluvio (nemolizumab) for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for… read more.
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