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
Aldeyra to Screen Clinical-Stage Compounds for Activity in COVID-19 Infection
LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 24, 2020 -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it will begin screening its library of novel reactive aldehyde species (RAS
Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients
VANCOUVER, Washington, March 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant
Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials
March 22, 2020 -- Gilead is working to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. Enrollment in clinical trial
U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab
VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant
Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome
BOSTON, March 18, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of ra
Novartis Announces NEJM Publication of Three Pivotal Trials Showing Durable and Potent Efficacy of Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Therapy
East Hanover, N.J., March 18, 2020 -- Novartis announced today the publication of three pivotal Phase III clinical trials for inclisiran, a potential first-in-class small interfering RNA (siRNA) inves
Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch
March 18, 2020 -- Pfizer Inc. (NYSE:PFE) announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an inve
FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder
South San Francisco, CA -- August 14, 2020 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the
FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy Print this page
PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ -- NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne
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