Media Room Menu
Month Year
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Month Year
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Mar 31, 2021- Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies
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Mar 15, 2021Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy
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Mar 12, 2021Fabrazyme is the only FDA-approved enzyme replacement therapy for Fabry disease with long-term efficacy and safety data
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Mar 4, 2021Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent
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Mar 3, 2021-One course of teplizumab delayed insulin dependence by approximately three years and improved beta cell function in at-risk (Stage 2) type 1 diabetes patients-
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Feb 25, 2021-U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021-
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Feb 22, 2021Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials
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Feb 18, 2021- Company also Announces Presentation at the 2021 SVB Leerink Global Healthcare Conference -
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Feb 18, 2021Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential to transform therapy and provide high sustained factor activity levels for people with hemophilia A
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Feb 17, 2021- Provention Bio to receive $6 million upfront payment; up to $11.5 million in research, development and manufacturing funding; and up to $172 million in potential development, regulatory and commercial milestone payments -
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Feb 9, 2021Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC
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Feb 1, 2021-- Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis
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Jan 28, 2021- PRV-3279 Murine Surrogate Inhibited the Production of Anti-adenoviral Vector Antibodies in a Mouse Model for Pompe Disease -
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Jan 4, 2021-FDA sets PDUFA goal date of July 2, 2021-
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Dec 15, 2020- Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -
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Nov 18, 2020Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Bruton’s tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia
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Nov 18, 2020The FDA decision date for avalglucosidase alfa, an investigational enzyme replacement therapy, is set for May 18, 2021
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Nov 13, 2020Complete Response Letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility
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Nov 5, 2020Oncology: Results from an interim analysis of Sarclisa® (isatuximab-irfc) in patients with relapsed multiple myeloma, including an evaluation of depth of response, will be shared in an oral presentation
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Nov 5, 2020- Completed rolling submission of the Biologics License Application (BLA) for teplizumab in the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals -
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Nov 3, 2020* Award recognizes innovative accomplishments in facility design, construction, and operation that are setting the standard for pharmaceutical facilities of the future
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Nov 2, 2020- Submission of chemistry, manufacturing and controls (CMC) and administrative information modules represent completion of the Company's BLA submission for teplizumab -
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Oct 27, 2020Results of two clinical studies in adults and children with acid sphingomyelinase deficiency (ASMD) presented at the American Society of Human Genetics 2020 Virtual Meeting
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Oct 26, 2020- First Phase 3 trial in eosinophilic esophagitis (EoE) to show a biologic medicine significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older
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Oct 21, 2020* $1 million in research funding to support PD GENEration, a first-of-its-kind national study offering free genetic testing and counseling for people with Parkinson's disease (PD)
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Oct 13, 2020Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option
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Oct 1, 2020- Healthcare professional and patient campaigns focus on screening for early-stage T1D-
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Sep 30, 2020- Expect to complete filing of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -
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Sep 21, 2020In the overall trial population, Libtayo reduced risk of death by 32% compared to chemotherapy
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Sep 18, 2020Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial
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Sep 14, 2020* Designation based on positive results from Part A of pivotal Phase 3 trial
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Sep 10, 2020BIVV001 is the first investigational factor VIII therapy independent of von Willebrand Factor and has the potential to transform replacement therapy for people with hemophilia A
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Sep 9, 2020- New data on investigational brain-penetrant BTK inhibitor tolebrutinib (SAR442168) further support its potential in modulating disabling inflammatory processes within the central nervous system
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Sep 8, 2020- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines
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Aug 31, 2020Potential to be the first approved therapeutic for the treatment of Non-responsive Celiac Disease
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Aug 17, 2020* Further strengthens core R&D areas of autoimmune and allergic diseases
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Aug 11, 2020-Former Director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, brings extensive regulatory expertise and experience to Provention-