Sierra Oncology Reports NDA Submission of Momelotinib to the US FDA for the Treatment of Myelofibrosis

Published: June 17, 2022 | Tags: Sierra Oncology, Momelotinib, Myelofibrosis, NDA, US, FDA,

Basilea and Pfizer Collaborated to Commercialize Cresemba for Invasive Aspergillosis and Mucormycosis

Published: June 17, 2022 | Tags: Basilea, Pfizer, Cresemba , Invasive Aspergillosis, Mucormycosis,

Addex Discontinue P-IIb/III Study of Dipraglurant for the Treatment of Dyskinesia Associated With Parkinson’s Disease

Published: June 17, 2022 | Tags: Addex, Dipraglurant, Parkinson’s Disease, P-IIb/III Study

Cordis’ Radianz Radial Peripheral System Used in First-in-Human Procedure for Vascular Disease

Published: June 17, 2022 | Tags: Cordis, Radianz Radial Peripheral System, Vascular Disease,

Checkpoint Therapeutics Reports Interim Results of Cosibelimab in Registration-Enabling Trial for Locally Advanced Cutaneous Squamous Cell Carcinoma

Published: June 17, 2022 | Tags: Checkpoint Therapeutics, Cosibelimab, Cutaneous Squamous Cell Carcinoma

Rhythm Receives the US FDA’s Approval for Imcivree (setmelanotide) sNDA to Treat Bardet-Biedl Syndrome

Published: June 17, 2022 | Tags: Rhythm, Imcivree, Bardet-Biedl Syndrome, Regulatory, US, FDA, sNDA

Genentech’s Crenezumab Fails to Meet Primary Endpoints in Alzheimer’s Disease with Cognitively Unimpaired Patients

Published: June 16, 2022 | Tags: Genentech, Crenezumab, Alzheimer’s Disease, Cognitively Unimpaired

Kintara’s VAL-083 Receives the US FDA’s Fast Track Designation for the Treatment of Newly Diagnosed Glioblastoma

Published: June 16, 2022 | Tags: Kintara, VAL-083, US, FDA, Fast Track Designation, Glioblastoma

Hansa Biopharma's Idefirix (imlifidase) Receives NICE Recommendation as Desensitization Treatment for Highly Sensitized Kidney Transplant Patients

Published: June 16, 2022 | Tags: Hansa Biopharma, Idefirix, imlifidase, NICE, Desensitization, Kidney Transplant

Faron Reports 12-Month Survival Results of Bexmarilimab in P-I/II (MATINS) Study for the Treatment of Solid Tumor

Published: June 16, 2022 | Tags: Faron, Bexmarilimab, P-I/II, MATINS Study, Solid Tumor

Adaptive Launches T-Detect Test for the Detection of Early Lyme Disease

Published: June 16, 2022 | Tags: Adaptive, T-Detect Test, Early Lyme Disease

Exelixis Entered into an Option and License Agreement with BioInvent to Develop Novel Antibody-Based Immuno-Oncology Therapies

Published: June 16, 2022 | Tags: Exelixis, Option, License, Agreement, BioInvent, Antibody-Based, Immuno-Oncology

Alchemedicine Entered into an Exclusive License Agreement with Asahi Kasei Pharma for Endothelin A Receptor Antagonist to Treat Chronic Kidney Disease

Published: June 15, 2022 | Tags: Alchemedicine, Asahi Kasei Pharma, Endothelin A, Receptor, Antagonist

The EMA and HMA Acquired Big Data Strategy to Folster Veterinary Therapies in the EU

Published: June 15, 2022 | Tags: EMA, HMA, Big Data Strategy, Veterinary, EU

Xenco Medical Expanded its ASC Surgical Device Portfolio with the Launch of Multilevel CerviKit

Published: June 15, 2022 | Tags: Xenco Medical, ASC, Surgical Device, Portfolio, Multilevel CerviKit

Pfizer Reports Updated Results of Paxlovid (nirmatrelvir and ritonavir) in the P-II/III (EPIC-SR) Trial for the Treatment of COVID-19

Published: June 15, 2022 | Tags: Pfizer, Paxlovid, nirmatrelvir, ritonavir, P-II/III, EPIC-SR Trial, COVID-19

Vyluma Entered into an Exclusive License Agreement with Théa for the Registration and Commercialization of NVK002 to Treat Myopia

Published: June 15, 2022 | Tags: Vyluma, Théa, NVK002, EU, Canada, Latin America, Myopia

MorphoSys Entered into a License Agreements with HIBio to Develop and Commercialize Felzartamab and MOR21 for Autoimmune and Inflammatory Diseases

Published: June 15, 2022 | Tags: MorphoSys, HIBio, Felzartamab, MOR21, Autoimmune, Inflammatory Diseases

Clover Reports the First Patient Dosing of SCB-2019 as a Heterologous Booster in P-III Trial for the Treatment of COVID-19

Published: June 14, 2022 | Tags: Clover, SCB-2019, Heterologous Booster, P-III Trial, COVID-19

Innovent Reports the NMPA Acceptance of NDA for Tafolecimab to Treat Primary Hypercholesterolemia and Mixed Dyslipidemia

Published: June 14, 2022 | Tags: Innovent, NMPA, NDA, Tafolecimab, Primary Hypercholesterolemia, Mixed Dyslipidemia

Eli Lilly and Incyte’ Olumiant (baricitinib) Receives the US FDA’s Approval as First-In-Disease Systemic Treatment for Adults with Severe Alopecia Areata

Published: June 14, 2022 | Tags: Eli Lilly, Incyte, Olumiant, baricitinib, US, FDA, Approval, Alopecia Areata

Lilly Entered into an Exclusive License Agreement with D. E. Shaw Research to Develop and Commercialize DES-7114 for Immunological and Inflammatory Diseases

Published: June 14, 2022 | Tags: Lilly, D. E. Shaw Research, DES-7114, Immunological, Inflammatory Diseases

Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Published: June 14, 2022 | Tags: Alnylam, Amvuttra, vutrisiran, US, FDA, Approval, Polyneuropathy, Hereditary, Transthyretin-Mediated Amyloidosis

Organon Entered into an Agreement with Henlius to Commercialize Perjeta (pertuzumab) and Prolia/Xgeva (denosumab) Biosimilars

Published: June 14, 2022 | Tags: Organon, Henlius, Perjeta, pertuzumab, Prolia, Xgeva, denosumab Biosimilars

Merck Reports the US FDA Acceptance of sBLA for Review of Keytruda (pembrolizumab) as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer

Published: June 13, 2022 | Tags: Merck, US, FDA, sBLA, Keytruda, pembrolizumab, Stage IB-IIIA, Non-Small Cell Lung Cancer

Cogent Presents Results of Bezuclastinib in P-II (APEX) Trial for the Treatment of Advanced Systemic Mastocytosis at EHA 2022

Published: June 13, 2022 | Tags: Cogent, Bezuclastinib, P-II, APEX Trial, Systemic Mastocytosis, EHA, 2022

Agios Presents Results of Pyrukynd (mitapivat) in P-III (ACTIVATE) Study for the Treatment of PK Deficiency at EHA 2022

Published: June 13, 2022 | Tags: Agios, Pyrukynd, mitapivat, P-III, ACTIVATE Study, PK Deficiency, EHA, 2022

Zavation’s eZspand Lateral Lumbar Interbody Fusion Device Receives the US FDA’s Clearance for the Treatment of Degenerative Disc Disease

Published: June 13, 2022 | Tags: Zavation, eZspand Lateral, Lumbar Interbody Fusion Device, US, FDA, Clearance Degenerative Disc Disease

Janssen Presents New and Updated Results of Imbruvica (ibrutinib) in P-II (CAPTIVATE) Study as Fixed-Duration Combination Regimen for CLL and SLL at EHA 2022

Published: June 13, 2022 | Tags: Janssen, Imbruvica, ibrutinib, P-II, CAPTIVATE Study, CLL, SLL, EHA, 2022

Daiichi Sankyo Presents Results of Quizartinib in P-III (QuANTUM-First) Study for the Treatment of FLT3-ITD Positive Acute Myeloid Leukemia at EHA2022

Published: June 13, 2022 | Tags: Daiichi Sankyo, Quizartinib, P-III, QuANTUM-First Study, FLT3-ITD, Acute Myeloid Leukemia, EHA2022

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