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FDA approves TNKase (tenecteplase) in acute ischemic stroke in adults – Genentech/ Roche

Written by | 13 Mar 2025

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.

FDA has approved Odactra tablet for use in young children with house dust mite allergy – ALK

Written by | 12 Mar 2025

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.

New and updated data for Roche’s fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma – Roche

Written by | 11 Mar 2025

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 Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine

Written by | 9 Mar 2025

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.

European Commission approves Nemluvio (nemolizumab) to treat moderate-to-severe atopic dermatitis and prurigo nodularis – Galderma

Written by | 8 Mar 2025

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.

Braftovi combination regimen demonstrates improved response in patients with BRAF V600E-mutant metastatic colorectal cancer – Pfizer

Written by | 7 Mar 2025

Pfizer Inc. announced positive results from the Phase III BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab  (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with… read more.

Seladelpar granted conditional European Marketing Authorization for the treatment of primary biliary cholangitis – Gilead Sciences

Written by | 6 Mar 2025

Gilead Sciences Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic… read more.

Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients

Written by | 5 Mar 2025

Eli Lilly and Company announced the launch of 7.5 mg and 10 mg Zepbound (tirzepatide) single-dose vials, available for $499 with the new Zepbound Self Pay Journey Program… read more.

Sandoz launches biosimilar Pyzchiva (ustekinumab-ttwe) in the US, offering new treatment for around 12 million patients

Written by | 4 Mar 2025

Sandoz, announces the launch of Pyzchiva (ustekinumab-ttwe) in the US. Developed by Samsung Bioepis Co., Ltd., and marketed by Sandoz, Pyzchiva has been approved by the FDA for… read more.

FDA approval of Vimkunya (vaccine) for chikungunya for persons aged 12 and older – Bavarian Nordic

Written by | 2 Mar 2025

Bavarian Nordic A/S announced that the FDA has approved Vimkunya (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons… read more.

New five-year Sotyktu (deucravacitinib) data show consistent safety and durable response rates in moderate-to-severe plaque psoriasis – BMS

Written by | 1 Mar 2025

Bristol Myers Squibb announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. The safety… read more.

Chenodal has received a medical necessity determination by the FDA for the treatment of cerebrotendinous xanthomatosis – Mirum Therapeutics

Written by | 28 Feb 2025

Chenodal has received a medical necessity determination by the FDA for the treatment of cerebrotendinous xanthomatosis. Because of the potential hepatoxicity of Chenodal, poor response rate in some… read more.

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