Pharma Press Releases

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Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder

Tuesday, December 31, 2019

Urovant Sciences announced today that it has submitted a New Drug Application NDA to the US Food and Drug Administration FDA seeking approval of oncedaily mg vibegron for the treatment of patients with overactive bladder OAB with symptoms of urge uri...

Clover Biopharmaceuticals Initiates Phase III Study of Etanercept Biosimilar Candidate SCB-808 in China

Tuesday, December 31, 2019

Clover Biopharmaceuticals a global clinicalstage biotechnology company focused on developing novel and transformative biologic therapies today announced that the first patient was dosed in a Phase III trial of SCB a proposed biosimilar to Enbrel etan...

Saudia launched SAL for ground handling and logistics services at Saudi Airports

Monday, December 30, 2019

Under the patronage and presence of His Excellency the Minister of Transport Saleh Bin Nasser AlJasser OnMonday December Saudi Arabian Airlines Saudia launched the Saudi Arabian Logistics SAL Co the new independent entity within the Saudia Group whi...

AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

Monday, December 30, 2019

AVITA Medical Limited a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration announced today that the US Food and Drug Administration FDA has approved the companys Investig...

Bridge Biotherapeutics Announces China NMPA Clearance of IND for BBT-401, a Pellino-1 Inhibitor for UC

Friday, December 27, 2019

Bridge Biotherapeutics Inc a clinical stage biotech company headquartered in Seongnam Republic of Korea announced that the Center for Drug Evaluation CDE of Chinas National Medical Products Administration NMPA cleared the Investigational New Drug IND...

Luye Pharma Submits New Drug Application in the U.S. for Its Antidepressant Drug LY03005

Friday, December 27, 2019

Luye Pharma Group has announced submission of a new drug application NDA to the US Food and Drug Administration FDA for LY a new chemical drug for the treatment of major depressive disorder It is also the second US FDA NDA submission in the central n...

Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

Tuesday, December 24, 2019

Gilead Sciences Inc and Eisai Co Ltd announced today that Gilead Sciences KK and Eisai have entered into an agreement for the distribution and copromotion of filgotinib an investigational oral selective JAK inhibitor in Japan pending regulatory appro...

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease

Tuesday, December 24, 2019

FibroGen Inc today announced the submission of a New Drug Application NDA to the US Food and Drug Administration FDA for roxadustat for the treatment of anemia of chronic kidney disease CKD in both nondialysisdependent NDD and dialysisdependent DD CK...

Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Helicobacter Pylori (H. pylori) Infection

Tuesday, December 24, 2019

Phathom Pharmaceuticals Inc a late clinicalstage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases announced today the initiation of PHALCONHP In this pivotal Phase clinical trial clin...

Polaryx Therapeutics Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200

Monday, December 23, 2019

Polaryx Therapeutics Inc a biotech company developing patientfriendly small molecule therapeutics for lysosomal storage disorders such as Late Infantile Neuronal Ceroid Lipofuscinosis LINCL and other forms of NCL announced today that the Company has...