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Nov 17, 2022, 09:30 ET Emmaus Life Sciences Receives Endari® Marketing Authorization from the Qatar Ministry of Public Health

Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today that it has been issued a Registration...

Nov 17, 2022, 09:00 ET See-Mode Technologies Receives Health Canada Approval for AI Software that Automatically Analyses and Reports Breast & Thyroid Ultrasound Scans

See-Mode Technologies, a MedTech company based in Australia that is on a mission to unlock the hidden insights within medical imaging, today...

Nov 17, 2022, 08:21 ET Upstaza™ Gene Therapy Granted Marketing Authorization for AADC deficiency by UK's MHRA

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Upstaza™ (eladocagene exuparvovec) was granted authorization by the Medicines and...

Nov 17, 2022, 08:17 ET Upstaza™ Gene Therapy Granted Marketing Authorization for AADC deficiency by UK's MHRA

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Upstaza™ (eladocagene exuparvovec) was granted authorization by the Medicines and...

Nov 16, 2022, 19:10 ET Ascletis Announces IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors by China NMPA

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today the approval of the Investigational New Drug (IND) application by China National...

Nov 14, 2022, 23:45 ET WuXi Vaccines Establishes New Vaccines CDMO Facility in China

WuXi Vaccines, a leading global Contract Development and Manufacturing Organization (CDMO), announced that it has entered into an agreement with...

Nov 13, 2022, 19:00 ET Akeso's Ivonescimab (PD-1/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China

Akeso, Biopharma (9926. HK) ("Akeso") announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration...

Nov 11, 2022, 06:59 ET Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Prurigo Nodularis

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for...

Nov 10, 2022, 21:30 ET J INTS BIO, Novel Oral 4th Generation EGFR TKI 'JIN-A02' - Phase 1/2 IND approved by US FDA

J INTS BIO announced on November 9th that it had received approval from the US FDA for its Phase 1/2 clinical trial of its Novel Oral 4th Generation...

Nov 10, 2022, 08:30 ET Caption Health Receives Regulatory Approvals for Caption AI™ Technology Platform in Canada and Australia

Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market...

Nov 09, 2022, 09:26 ET Novavax Nuvaxovid™ COVID-19 Vaccine▼ Authorized in the United Kingdom for Use as a Booster in Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Nov 09, 2022, 09:19 ET Novavax Nuvaxovid™ COVID-19 Vaccine▼ Authorized in the United Kingdom for Use as a Booster in Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Nov 01, 2022, 09:17 ET Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC

Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic ...

Nov 01, 2022, 08:07 ET MIM Software Inc. Receives Health Canada Approval for AI Auto-Contouring Software

MIM Software Inc., a leading global provider of medical imaging software, announced today it has received approval from Health Canada for its AI...

Oct 31, 2022, 09:00 ET BRONCUS'S DISPOSABLE NEBULIZING MICRO-CATHETER FOR ENDOSCOPE WAS APPROVED FOR MARKETING IN CHINA AND ITS APPLICATIONS IN DRUG-DEVICE COMBINATION WILL BE BROADENED

Broncus is pleased to announce that on October 28, 2022, the Company's innovative product in the field of drug-device combination, "Mist FountainTM"...

Oct 31, 2022, 08:59 ET ABM RESPIRATORY CARE RECEIVES CE MARK CERTIFICATE FOR BIWAZE COUGH

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and...

Oct 29, 2022, 13:40 ET Pharming anuncia que Agência Europeia de Medicamentos (EMA) valida sua Solicitação de Autorização de Comercialização sob avaliação acelerada para leniolisibe

O Pharming Group N.V. ("Pharming" ou "a Empresa") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) anunciou hoje sua Solicitação de Autorização de...

Oct 29, 2022, 13:34 ET Pharming gibt bekannt, dass die Europäische Arzneimittelagentur (EMA) ihren Zulassungsantrag im Rahmen einer beschleunigten Bewertung für Leniolisib validiert hat

Pharming Group N.V. („Pharming" oder „das Unternehmen") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) gibt heute bekannt, dass sein Zulassungsantrag...

Oct 29, 2022, 13:25 ET Pharming annonce que l'Agence européenne des médicaments (EMA) valide sa demande d'autorisation de mise sur le marché dans le cadre de l'évaluation accélérée pour le léniolisib

Pharming Group N.V. (« Pharming » ou « la Société ») (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) annonce aujourd'hui que sa demande d'autorisation de...

Oct 29, 2022, 07:00 ET Pharming anuncia que la Agencia Europea de Medicamentos (EMA) validó su solicitud de autorización de comercialización bajo evaluación acelerada para el leniolisib

Pharming Group N.V. ("Pharming" o "la Compañía") (EURONEXT Ámsterdam: PHARM / Nasdaq: PHAR) anunció hoy que su solicitud de autorización de...

Oct 28, 2022, 07:37 ET Pharming anuncia que la EMA valida su solicitud de autorización para comercializar leniolisib

Pharming Group N.V. ("Pharming" o "la compañía") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) anuncia hoy que su Solicitud de Autorización de...

Oct 28, 2022, 01:00 ET Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation...

Oct 28, 2022, 01:00 ET Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation...

Oct 26, 2022, 08:42 ET Perinatal Stem Cell Society Calls Emergency Session to Garner Industry Support for FDA

The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with...

Oct 26, 2022, 07:35 ET New Reimbursement Approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife® System to Treat Trigeminal Neuralgia, a Condition Often Causing Severe Facial Pain

Accuray Incorporated (NASDAQ: ARAY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved reimbursement for the ...