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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.

Pfizer withdraws fidanacogene elaparvovec globally

Written by | 27 Feb 2025

Pfizer has decided to terminate the development and commercialization of its hemophilia B gene therapy fidanacogene elaparvovec (marketed as Beqvez) globally, resulting in the withdrawal of its regulatory… read more.

NICE (UK) positive for Vafseo (vadadustat) for treating symptomatic anaemia in adults having dialysis for chronic kidney disease – Akebia Theraputics

Written by | 26 Feb 2025

NICE (UK): 1.1 Vadadustat is recommended, within its marketing authorisation, as an option for treating symptomatic anaemia caused by chronic kidney disease in adults having maintenance dialysis. Vadadustat… read more.

CHMP positive for seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid – Gilead Sciences

Written by | 25 Feb 2025

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the… read more.

Penmenvy, meningococcal vaccine, approved by FDA to help protect against MenABCWY – GSK

Written by | 24 Feb 2025

GSK plc announced that the FDA has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The… read more.

CHMP recommends Tivdak (tisotumab vedotin) to treat recurrent or metastatic cervical cancer – Pfizer

Written by | 22 Feb 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tivdak, ( tisotumab vedotin) intended for the… read more.

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