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Zevra Therapeutics presents positive new real-world data on Miplyffa (arimoclomol) in patients with Neimann-Pick Disease Type C at the 22nd Annual WORLDSymposium

Written by | 16 Feb 2026

Zevra Therapeutics announced the presentation of four posters highlighting positive new data on Miplyffa (arimoclomol) for the treatment of Niemann-Pick Disease Type C (NPC) at the 22nd Annual… read more.

Neffy (epinephrine) 1 mg and 2 mg launched in Japan as emergency supportive therapy to suppress anaphylaxis – Alfresa Pharma

Written by | 15 Feb 2026

Alfresa Pharma released Neffy 1 mg and Neffy 2 mg (adrenaline, epinephrine), which are nasal sprays used as emergency supportive therapy to suppress anaphylaxis, to the Japanese market…. read more.

Nucala (mepolizumab) approved in China for use in adults with chronic obstructive pulmonary disease – GSK

Written by | 14 Feb 2026

GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterised by raised blood… read more.

Ycanth (cantharidin) topical solution 0.71% for the treatment of molluscum contagiosum launched in Japan – Torii Pharma/Shionogi

Written by | 13 Feb 2026

Shionogi & Co., Ltd. announces that its group company, Torii Pharmaceutical Co., Ltd., has issued a press release about the launch in Japan of Ycanth (cantharidin)  topical solution… read more.

Tzield (teplizumab) accepted for priority review in the US for young children with stage 2 type 1 diabetes – Sanofi

Written by | 12 Feb 2026

The FDA has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to… read more.

NICE (UK) positive for Bavencio (avelumab) with axitinib for untreated advanced renal cell carcinoma – Merck Serono

Written by | 11 Feb 2026

NICE (UK): Avelumab plus axitinib can be used as an option for untreated advanced renal cell carcinoma (RCC) in adults, only if: i) they have a favourable-risk status,… read more.

Health Canada has issued a market authorization with conditions for Voxzogo (vosoritide for injection) for the treatment of achondroplasia – Biomarin International

Written by | 10 Feb 2026

Health Canada has issued a Notice of Compliance with conditions (NOC/c) for Voxzogo (vosoritide for injection) a modified recombinant human C-type natriuretic peptide 39 (CNP-39) for the treatment… read more.

Trodelvy added as preferred regimen within first-line metastatic triple-negative breast cancer in NCCN (Clinical Practice) Guidelines in Oncology – Gilead Sciences

Written by | 9 Feb 2026

Gilead Sciences Inc. announced Trodelvy (sacituzumab govitecan-hziy) has now been added to the NCCN Guidelines as a category 1 preferred first-line treatment option for people with metastatic triple-negative… read more.

Finerenone recommended by CHMP for the treatment of patients with heart failure with LVEF ≥40% in the EU – Bayer

Written by | 8 Feb 2026

Bayer announced that the CHMP of the  EMA has adopted a positive opinion recommending finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adults… read more.

FDA Approves Zycubo (copper histidinate) for the Treatment of Menkes Disease in Paediatric Patients – Cyprium Therapeutics

Written by | 7 Feb 2026

Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration has approved ZYCUBO (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric… read more.

RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older – GSK

Written by | 6 Feb 2026

GSK plc announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the European Commission (EC) for use in adults aged 18 years… read more.

Medtronic Diabetes expands access to full-stack insulin delivery solutions with Medicare access and new FDA clearances

Written by | 5 Feb 2026

Medtronic announced significant U.S. milestones that expand access, choice, and flexibility for people living with type 1 and insulin‑requiring type 2 diabetes. These milestones include FDA clearance for… read more.

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