FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus – CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S.

VANCOUVER, Washington, May 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antag

Latest News Clinical News 696
Read All

Lilly and Junshi Biosciences to Co-develop Antibody Therapies for the Prevention and Treatment of COVID-19

SHANGHAI and INDIANAPOLIS, May 4, 2020 /PRNewswire/ -- Junshi Biosciences (HKEX: 1877) and Eli Lilly and Company (NYSE: LLY) announced today they have entered into an agreement to co-develop therapeut

Latest News Clinical News 642
Read All

Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 1, 2020 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA)

Latest News Clinical News 696
Read All

Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus

CAMBRIDGE, Mass. & BASEL, Switzerland--(BUSINESS WIRE)--May 1, 2020 -- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccine

Latest News Clinical News 689
Read All

TG Therapeutics Announces Publication of Ublituximab Phase 2 Clinical Trial Results in Multiple Sclerosis Journal

NEW YORK, May 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab, the Company’s inve

Latest News Clinical News 977
Read All

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 24, 2020 -- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA)

Latest News NDA News 949
Read All

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

PALO ALTO, Calif., Nov. 20, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare di

Latest News NDA News 1072
Read All

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation

BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ -- Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassi

Latest News NDA News 1101
Read All

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

PAOLI, Pa., -- (BUSINESS WIRE) -- November 9, 2020 -- Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium fo

Latest News NDA News 940
Read All

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food

Latest News NDA News 1584
Read All

FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease

WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 27, 2020 -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative ther

Latest News NDA News 777
Read All

Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15

Saint Herblain (France) and New York, NY, April 30, 2020 -- Valneva SE (“Valneva”), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced a collaboration to develop and commercializ

Latest News Clinical News 898
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism