IASO Biotherapeutics' Equecabtagene Autoleucel Receives the NMPA’s IND Approval for Neuromyelitis Optica Spectrum Disorder

Published: Aug 19, 2022 | Tags: IASO Biotherapeutics, Equecabtagene Autoleucel, Neuromyelitis Optica Spectrum Disorder, Regulatory, NMPA, IND, Approval

IMPACT Therapeutics’ IMP4297 and Temozolomide Receives the US FDA’s Orphan Drug Designation for Small Cell Lung Cancer

Published: Aug 19, 2022 | Tags: IMPACT Therapeutics, IMP4297, Temozolomide, Small Cell Lung Cancer, Regulatory, US, FDA, Orphan Drug Designation

Menarini Reports EMA's Validation of MAA for Elacestrant to Treat ER+/HER2- Advanced or Metastatic Breast Cancer

Published: Aug 19, 2022 | Tags: Menarini, Elacestrant, ER+/HER2- Advanced, Metastatic Breast Cancer, Regulatory, EMA, MAA

Aeglea BioTherapeutics Reports the Validation of EMA's MAA for Pegzilarginase to Treat Arginase 1 Deficiency

Published: Aug 19, 2022 | Tags: Aeglea BioTherapeutics, Pegzilarginase, Arginase 1 Deficiency, Regulatory, EMA, MAA

Agios Publishes P-III (ACTIVATE-T) Study Results of Pyrukynd (mitapivat) for Pyruvate Kinase Deficiency in The Lancet Haematology

Published: Aug 19, 2022 | Tags: Agios, Pyrukynd, mitapivat, Pyruvate Kinase Deficiency, P-III (ACTIVATE-T) Study, Lancet Haematology

Jazz Reports the Initiation of Epidiolex/Epidyolex (cannabidiol) in P-III (GWEP20238) Trial for Epilepsy Associated with Myoclonic-Atonic Seizures

Published: Aug 19, 2022 | Tags: Jazz, Epidiolex, Epidyolex, cannabidiol, Epilepsy, Myoclonic-Atonic Seizures, P-III GWEP20238 Trial

CSL Vifor’s Tavneos (avacopan) Receives NICE Recommendation for the Treatment of Anca-Associated Vasculitis (GPA/MPA)

Published: Aug 18, 2022 | Tags: CSL Vifor, Tavneos, avacopan, Anca-Associated Vasculitis, GPA, MPA, NICE, Regulatory

Genentech Entered into an Exclusive WW License Agreement with Jemincare to Develop and Commercialize JMKX002992 for Prostate Cancer

Published: Aug 18, 2022 | Tags: Genentech, Jemincare, JMKX002992, Prostate Cancer, Pharma

Blueprint Medicines Reports (PIONEER) Trial Results of Ayvakit (avapritinib) for the Treatment of Non-Advanced Systemic Mastocytosis

Published: Aug 18, 2022 | Tags: Blueprint Medicines, Ayvakit, avapritinib, Non-Advanced Systemic Mastocytosis, Clinical trial, PIONEER Trial

GSK Reports the US FDA’s Acceptance of NDA for Momelotinib to Treat Myelofibrosis

Published: Aug 18, 2022 | Tags: GSK, Momelotinib, Myelofibrosis, Regulatory, US, FDA, Acceptance, NDA

bluebird bio’s Zynteglo (betibeglogene autotemcel) Receives the US FDA’s Approval for the Treatment of Beta-Thalassemia

Published: Aug 18, 2022 | Tags: bluebird bio, Zynteglo, Beta-Thalassemia, Regulatory, US, FDA, Approval

Sanofi Entered into a Multi-Target Research Collaboration with Atomwise for AI-Powered Drug Discovery

Published: Aug 18, 2022 | Tags: Sanofi, Atomwise, AI-Powered Drug Discovery, Pharma, AtomNet platform

Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive the US FDA’s Approval for Chronic Autoimmune Diseases

Published: Aug 17, 2022 | Tags: Samsung Bioepis, Organon, Hadlima, biosimilar, adalimumab, Chronic Autoimmune Diseases Regulatory, US, FDA, Approval

Tessa Reports First Patient Dosing in P-Ib Clinical Trial of TT11 as 2L Treatment of Relapsed/Refractory Classical Hodgkin Lymphoma

Published: Aug 17, 2022 | Tags: Tessa, TT11, Classical Hodgkin Lymphoma, Clinical Trial, P-Ib Trial

Chugai and Towa’s Edirol Receive the MHLW Approval for the Treatment of Osteoporosis

Published: Aug 17, 2022 | Tags: Chugai, Towa, Edirol, Osteoporosis, Regulatory, MHLW, Approval

Sanofi Discontinue P-III (AMEERA-5) Trial of Amcenestrant for the Treatment of ER+/HER2- Advanced Breast Cancer

Published: Aug 17, 2022 | Tags: Sanofi, Amcenestrant, ER+/HER2- Advanced Breast Cancer, Clinical Trial, P-III AMEERA-5 Trial

Tris Pharma Reports the Availability of Dyanavel XR (amphetamine) Tablets for Attention Deficit Hyperactivity Disorder

Published: Aug 17, 2022 | Tags: Tris Pharma, Dyanavel XR, amphetamine, Attention Deficit Hyperactivity Disorder, Regulatory, Journal of Clinical Psychiatry

Medison Expands its Partnership with Albireo to Commercialize Odevixibat in Canada and Israel for Cholestatic Liver Diseases

Published: Aug 17, 2022 | Tags: Medison, Albireo, Odevixibat, Cholestatic Liver Diseases, Pharma, Canada, Israel

Merck Collaborated with Orna Therapeutics to Advance RNA Therapies for Infectious Disease and Oncology

Published: Aug 16, 2022 | Tags: Merck, Orna Therapeutics, RNA Therapies, Infectious Disease, Oncology, Biotech, oRNA-LNP technology platform

Genentech Reports the US FDA Acceptance of sBLA for Polivy (polatuzumab vedotin-piiq) to Treat Diffuse Large B-Cell Lymphoma

Published: Aug 16, 2022 | Tags: Genentech, Polivy, polatuzumab vedotin-piiq, Diffuse Large B-Cell Lymphoma, Regulatory, US FDA, sBLA

Guardant Health Reports the Availability of Guardant Reveal Liquid Biopsy Test for the Detection of Residual Disease and Recurrence of Early-Stage Breast and Lung Cancers

Published: Aug 16, 2022 | Tags: Guardant Health, Guardant Reveal Liquid Biopsy Test, MedTech, Breast, Lung Cancers

Gilead Reports Second Interim P-III (TROPiCS-02) Study Results of Trodelvy (sacituzumab govitecan-hziy) for HR+/HER2- Metastatic Breast Cancer

Published: Aug 16, 2022 | Tags: Gilead, Trodelvy, sacituzumab govitecan-hziy, HR+/HER2- Metastatic Breast Cancer, Clinical Trials, P-III TROPiCS-02 Study

Horizon Entered into an Option Agreement with Q32 Bio to Develop ADX-914 for the Treatment of Autoimmune Diseases

Published: Aug 16, 2022 | Tags: Horizon, Q32 Bio, ADX-914, Autoimmune Diseases, Pharma

Gilead Entered into an Agreement with Everest to Develop and Commercialize Trodelvy (sacituzumab govitecan) in Asia Territories

Published: Aug 16, 2022 | Tags: Gilead, Everest, Trodelvy, sacituzumab govitecan, Metastatic Triple-Negative Breast Cancer, Asia

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