FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
PRINCETON, N.J.--(BUSINESS WIRE) September 1, 2020 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets,
FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair
ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ -- Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug
FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency
Plainsboro, NJ, Aug 28, 2020 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10
Investigational Drug Vericiguat Significantly Reduced the Risk of the Composite Endpoint of Heart Failure Hospitalization or Cardiovascular Death, Compared to Placebo, When Given in Combination with Available Heart Failure Therapies
KENILWORTH, N.J.--(BUSINESS WIRE) March 28, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the VICTORIA trial, a Phase 3
FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne
Lainate, Italy – August 27, 2020 – Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of ac
Novartis New Analysis Further Shows Durable and Potent LDL-C Reduction with Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Treatment
East Hanover, N.J., March 28, 2020 -- Novartis today announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its fi
Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation
VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant
CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients
VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant
Atlanta Site Added to NIH Clinical Trial of a Vaccine for COVID-19
March 27, 2020 -- Emory University in Atlanta will begin enrolling healthy adult volunteers ages 18 to 55 years in a Phase 1 clinical trial of an investigational vaccine designed to prevent coronaviru
Sanofi and Translate Bio Collaborate to Develop Novel mRNA Vaccine Candidate Against COVID-19
PARIS and LEXINGTON, MASS. - March 27, 2020 -- Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company
FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis
Basel, August 20, 2020 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the trea
Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation
March 25, 2020 -- Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the tre
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