Press Releases
Looking for more press releases? Explore our full press release archive by date to access past announcements, news updates, and media releases published on Health Monitor Liechtenstein.
Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis
Benzinga
·
November 1, 2022
NEWTON, Mass. and FLORENCE, Italy, Oct. 31, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. KPTI, a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading...
European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy
GlobeNewswire, Inc.
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October 31, 2022
Pratteln, Switzerland, October 31, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular...
Neuraxpharm steps into the Digital Health market with a wearable device developed by mjn-neuro that provides an early warning of epileptic seizures
Benzinga
·
October 25, 2022
The CNS specialist Neuraxpharm has signed a commercialisation agreement with mjn-neuro with exclusivity in Europe DÜSSELDORF, Germany, Oct. 25, 2022 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical...
PolyPid Announces Eligibility for European Medicines Agency Centralized Procedure for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery
GlobeNewswire, Inc.
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September 28, 2022
Centralized Procedure Allows for Submission of a Single Marketing Application to the European Medicines Agency that, if Approved, Would Allow D-PLEX100 to be Marketed in All EU Member States D-PLEX100 is Eligible for Centralized Procedure Under...
LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis
Benzinga
·
September 19, 2022
Positive CHMP opinion recommends extending use of Adtralza® (tralokinumab) to adolescents (12-17 years old) in the European Union (EU) Recommendation supported by data from the Phase 3 ECZTRA 6 trial NOT FOR DISTRIBUTION IN THE UK LEO Pharma A/S,...
BridgeBio Pharma and Sentynl Therapeutics Receive Marketing Authorization in the EU for NULIBRY® (fosdenopterin) for the Treatment of MoCD Type A
GlobeNewswire, Inc.
·
September 20, 2022
- The first and only treatment in Europe to treat patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about...
CHMP Recommends Approval of Atara Biotherapeutics' Ebvallo™ (tabelecleucel) for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease
Benzinga
·
October 14, 2022
EbvalloTM on Track to be the First Ever Allogeneic T-Cell Therapy Approved Positive Opinion Based on Pivotal Phase 3 ALLELE Study Demonstrating a Favorable Risk-Benefit Profile European Commission Approval Expected in Q4 2022 Atara...
InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones
GlobeNewswire, Inc.
·
March 20, 2025
Received European Commission approval for GOHIBIC® (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG)...
Orchard Therapeutics Announces Multiple Presentations at 2022 SSIEM Annual Symposium Highlighting Neurometabolic Disease Portfolio
Benzinga
·
August 29, 2022
BOSTON and LONDON, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Orchard Therapeutics ORTX, a global gene therapy leader, today announced seven presentations from across its neurometabolic portfolio will be featured at the Society for the Study of Inborn...
Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
GlobeNewswire, Inc.
·
February 28, 2025
PITTSBURGH, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement that its Committee for Medicinal...
Buying veterinary medicines online
European Medicines Agency
·
January 18, 2022
To stay safe when buying veterinary medicines online, look out for the official logo. The official logo should display on the websites of all online veterinary medicine retailers registered with their national regulatory authority in an EU Member...
Ligand Reports Fourth Quarter and Full Year 2024 Financial Results
GlobeNewswire, Inc.
·
February 27, 2025
Robust financial performance driven by full year 2024 royalty revenue growth of 28% Reiterating 2025 financial guidance of $180-$200 million in revenues and adjusted earnings per diluted share1 of $6.00-$6.25 Conference call and webcast at 8:30...
Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates
GlobeNewswire, Inc.
·
March 29, 2025
SHANGHAI, March 28, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization...
Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in EU for Adolescents Aged 12 and Above
GlobeNewswire, Inc.
·
April 1, 2025
With this extension, IXCHIQ®, the first vaccine against the chikungunya virus (CHIKV), is now available for administration for individuals 12 years of age and older in the European Union (EU). Saint Herblain (France), April 1, 2025 – Valneva SE...
GW Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
GlobeNewswire, Inc.
·
April 20, 2021
– Tuberous sclerosis complex (TSC) represents a third indication for GW’s cannabidiol in Europe – – TSC causes epilepsy in up to 85% of patients, and up to 60% of those patients do not respond to standard anti-epileptic medicines1,2,3 – LONDON,...
VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin
GlobeNewswire, Inc.
·
March 30, 2021
Companies have successfully submitted the EU regulatory application for marketing authorization for difelikefalin If approved, difelikefalin injection will be the first therapy available in Europe for treatment of pruritus associated with chronic...
GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated with Tuberous Sclerosis Complex
GlobeNewswire, Inc.
·
February 26, 2021
LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the Group”), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the...
Orchard Therapeutics Announces Interim Data for OTL-203 Showing Positive Clinical Results in Multiple Disease Manifestations of Mucopolysaccharidosis Type I Hurler Syndrome (MPS-IH)
GlobeNewswire, Inc.
·
February 9, 2021
All eight patients treated with OTL-203 show stable cognitive function, motor function and growth within the normal range at multiple data points post-treatment Supportive initial OTL-201 biomarker data for mucopolysaccharidosis type IIIA...
Basilea’s partner Asahi Kasei Pharma completes patient enrolment in phase 3 study with antifungal isavuconazole (Cresemba®) in Japan
GlobeNewswire, Inc.
·
January 7, 2021
Basel, Switzerland, January 07, 2021 Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that patient enrolment has been completed in the phase 3 study with the antifungal isavuconazole (Cresemba®), which is conducted in Japan by Basilea’s...
Orchard Therapeutics Announces OTL-200 Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by FDA for the Treatment of Metachromatic Leukodystrophy (MLD)
GlobeNewswire, Inc.
·
January 14, 2021
BOSTON and LONDON, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT)...