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Mar 23, 2023, 23:23 ET EMA validiert Antrag auf Marktzulassung für Henlius' HANSIZHUANG (Serplulimab)

Shanghai Henlius Biotech, Inc. (2696.HK) gab bekannt, dass die Europäische Arzneimittel-Agentur (EMA) den Antrag für seinen selbst entwickelten...

Mar 23, 2023, 12:21 ET La EMA valida la solicitud de autorización de comercialización de HANSIZHUANG (Serplulimab) de Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) ha anunciado que la Agencia Europea del Medicamento (EMA) ha validado la solicitud de su anti-PD-1 mAb...

Mar 23, 2023, 11:28 ET EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed...

Mar 22, 2023, 08:50 ET CARsgen Announced 2022 Annual Results and Business Updates

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic...

Mar 21, 2023, 08:45 ET Neogen® Viroxide Super™ Receives New Label Claims in U.S. and Canada

Neogen Corporation (NASDAQ: NEOG) announced today that the U.S. Environmental Protection Agency (EPA) has approved additional virucide claims to its...

Mar 20, 2023, 09:00 ET Lunit Meets MDR CE Requirements for 3D Breast Tomosynthesis AI Solution

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis...

Mar 20, 2023, 09:00 ET Lunit Meets MDR CE Requirements for 3D Breast Tomosynthesis AI Solution

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis...

Mar 17, 2023, 09:00 ET China's first personalized neoantigen-targeted cancer vaccine receives NMPA's clinical trial approval

According the latest data released at the Clinical Trials Implied Approval section on the website of China's Center for Drug Evaluation (CDE) of the...

Mar 16, 2023, 08:38 ET MedGuard CEO Sean Stapleton to Speak at 2023 Medtrade Conference

MedGuard Protection Plans (MedGuard), announces that its CEO, Sean Stapleton, has been selected to speak at the 2023 Medtrade Conference. Since 1979, ...

Mar 15, 2023, 08:00 ET MEDTRONIC ERHÄLT CE-KENNZEICHNUNG FÜR DAS AFFERA™ MAPPING- UND ABLATIONSSYSTEM ZUR BEHANDLUNG ATRIALER ARRHYTHMIEN  

Medtronic (NYSE:MDT) gab heute bekannt, dass das Unternehmen die CE-Kennzeichnung (Conformité Européenne) für das Affera™ Mapping- und...

Mar 15, 2023, 08:00 ET Medtronic receives CE Mark approval for Affera™ Mapping and Ablation System to treat atrial arrhythmias

Medtronic (NYSE:MDT) announced today that it has received CE (Conformité Européenne) Mark for the Affera™ Mapping and Ablation System, which includes ...

Mar 15, 2023, 03:45 ET Bioprojet: WAKIX (pitolisant) recibe la autorización para el tratamiento de la narcolepsia en niños a partir de 6 años

La Agencia Europea del Medicamento acaba de conceder una ampliación de indicación de la autorización de comercialización de WAKIX® (pitolisant),...

Mar 15, 2023, 03:42 ET Bioprojet: WAKIX® (Pitolisant) erhält die Zulassung für die Behandlung von Narkolepsie bei Kindern über 6 Jahren, einer seltenen, unterdiagnostizierten Erkrankung

Die Europäische Arzneimittelagentur EMA hat der Zulassung von WAKIX® (Pitolisant) eine Indikationserweiterung gewährt. Das Medikament ist nun für die ...

Mar 15, 2023, 03:38 ET Laboratoire Bioprojet : WAKIX (pitolisant) reçoit une autorisation dans le traitement de la narcolepsie de l’enfant de plus 6 ans, une maladie rare sous-diagnostiquée

L'Agence Européenne du Médicament vient d'accorder une extension d'indication à l'autorisation de mise sur le marché de WAKIX® (pitolisant),...

Mar 15, 2023, 03:32 ET Bioprojet: WAKIX® (pitolisant) receives approval for the treatment of narcolepsy in children over 6 years of age, a rare, under-diagnosed condition

The European Medicines Agency has just granted an extension of the indication for the marketing authorisation for WAKIX® (pitolisant), which is now...

Mar 09, 2023, 02:00 ET Mallinckrodt gibt Genehmigung der Kostenerstattung in Japan für CELLEX® Extrakorporales Photopherese (ECP) -System zur Behandlung der chronischen Graft Versus Host Disease (dt. Transplantat-gegen-Wirt-Reaktion, cGvHD) bekannt

Mallinckrodt plc,(NYSE American: MNK) („Mallinckrodt" oder das „Unternehmen"),ein weltweit tätiges Spezialpharmaunternehmen, gab heute bekannt, dass...

Mar 07, 2023, 10:24 ET SUS INCORPORA TRATAMENTO PARA MULHERES COM OSTEOPOROSE NA PÓS-MENOPAUSA(1)

O Brasil terá um novo tratamento disponível para combater a osteoporose. O Ministério da Saúde confirmou a inclusão do romosozumabe no Sistema Único...

Mar 07, 2023, 07:01 ET Identifai-Genetics Wins Israel Innovation Authority (IIA) Approval and Participation in a USD 2.5M Budget R&D Plan

Identifai-Genetics, developer of unique AI-based solutions for non-invasive fetal DNA sequencing, announced today that it received the Israel...

Mar 01, 2023, 06:00 ET GenFleet receives EMA approval for phase Ib/II study of GFH925 (KRAS G12C inhibitor) in combination with ERBITUX® (cetuximab) treating patients with advanced NSCLC in first-line setting

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced today that...

Feb 28, 2023, 10:00 ET First in Class, Mabwell Announces the TGA Approval of 9MW3811 for IND

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that its IND application of its...

Feb 28, 2023, 09:16 ET FDA Grants Orphan Drug Designation to Ymmunobio's CEACAM Antibody for the Treatment of Liver Cancer

Ymmunobio, a preclinical stage biotech company specializing in the development of innovative treatments for cancer patients, announced today that it...

Feb 28, 2023, 08:00 ET Dynavax Announces Great Britain Marketing Authorization for HEPLISAV B®, a Two-Dose Adult Hepatitis B Adjuvanted Vaccine

Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing innovative vaccines, today...

Feb 24, 2023, 09:19 ET Karyopharm et le groupe Menarini reçoivent une autorisation de mise sur le marché complète de NEXPOVIO® (selinexor) de la UK Medicines & Healthcare Products Regulatory Agency en combinaison avec le bortézomib et la dexaméthasone pour le traitement des patients adultes atteints de myélome multiple qui ont reçu au moins un traitement antérieur

Karyopharm Therapeutics Inc. (Nasdaq: KPTI), une société pharmaceutique au stade commercial, pionnière dans le domaine des nouvelles thérapies contre ...
Servier receives a positive CHMP opinion for Tibsovo® in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients

Feb 24, 2023, 07:10 ET Servier receives a positive CHMP opinion for Tibsovo® in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients

Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

Feb 22, 2023, 12:41 ET Pharming annonce le premier patient inscrit à un essai clinique pédiatrique sur le leniolisib

L'étude multinationale de phase III évalue les comprimés de leniolisib chez les enfants de 4 à 11 ans atteints d'une immunodéficience primaire rare,...