FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsych
Statement on Boosting with the Johnson & Johnson COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 18, 2021 -- We are engaging with the U.S. FDA, CDC and other health authorities and will share new data shortly regarding boosting with the Johnson & Johnson COVID-19 v
Lilly's Lebrikizumab Significantly Improved Skin Clearance and Itch in People with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials
INDIANAPOLIS, Aug. 16, 2021 /PRNewswire/ -- Lebrikizumab led to significant improvements with at least 75 percent skin clearance in more than half of people with moderate-to-severe atopic dermatitis (
Moderna Announces First Patient Dosed in Phase 1/2 Study of mRNA-3705 for Methylmalonic Acidemia
mRNA-3705 is Moderna’s second rare disease program to enter clinical studies mRNA-3705 granted Orphan Drug and Rare Pediatric Disease designation by the U.S. FDA MMA associated with significant mortal
FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency
COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new trea
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2
FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients
STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has ap
Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study
London UK and Tübingen, Germany / Boston, USA -16 August 2021 Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureV
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2
Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine
Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses The booster dose e
VTX-801 Receives U.S. FDA Fast Track Designation for the Treatment of Wilson Disease
Paris, France and New York, NY, August 12, 2021 -- Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administrati
FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
KENILWORTH, N.J.--(BUSINESS WIRE) August 13, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved
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