Tokyo, Japan and Cambridge, UK, 2 June 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”) announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026.
Pratteln, Switzerland, 13 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) for the distribution and promotion of AGAMREE® (vamorolone) in Türkiye for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults
Accelerated approval based on an...
New York City, NY, July 29, 2025 (GLOBE NEWSWIRE) --
In 2025, PhenQ is setting a new standard for belly fat burners with its research-driven, natural solution, providing powerful, long-lasting support for a slimmer, healthier stomach without injections or unwanted side effects, and supporting a healthier, more sustainable lifestyle.
The opinion will now be referred to the European Commission for final regulatory decision on donanemab
INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and...
NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”2
Extended-release buprenorphine (BUP-XR) had lower rates of hospitalizations, emergency department (ED) visits, and outpatient physician office visits compared to those receiving daily oral buprenorphine or no medications for...
BOSTON, July 22, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, August 5, 2025 to report its second quarter 2025 financial results and provide a corporate update.
New York City, NY, July 21, 2025 (GLOBE NEWSWIRE) -- PhenQ is leading the 2025 weight loss revolution with a science-backed natural appetite suppressant—no needles, no harsh side effects, just sustainable, healthy weight control
– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –
– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –
– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –
– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –
EURneffy (neffy® in the U.S.) offers a new delivery method for adrenaline in the U.K. for adults and children (>30 kg) living with severe allergic reactions