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

Latest News NDA News 294
Read All

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

Latest News Clinical News 241
Read All

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

Latest News NDA News 259
Read All

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

Latest News Clinical News 239
Read All

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

Latest News Clinical News 263
Read All

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

Latest News NDA News 296
Read All

Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008)

CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE) August 5, 2021 -- Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technol

Latest News Clinical News 372
Read All

Pfizer Announces Positive Top-Line Results from Phase 2b/3 Trial of Ritlecitinib in Alopecia Areata

NEW YORK--(BUSINESS WIRE) August 04, 2021 -- Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients wit

Latest News Clinical News 1298
Read All

New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection

TARRYTOWN, N.Y., Aug. 4, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) published positive detailed results from a

Latest News Clinical News 270
Read All

Complete Response Letter Received from FDA for Treosulfan

TORONTO and CHICAGO and WEDEL, Germany, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) announced today t

Latest News Clinical News 263
Read All

FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease

PARIS – August 6, 2021 -- The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe

Latest News NDA News 255
Read All

SpringWorks Therapeutics Announces Phase 1b/2a Clinical Trial of Mirdametinib in Patients with Advanced Solid Cancers Harboring MAPK-Activating Mutations

STAMFORD, Conn., Aug. 03, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients

Latest News Clinical News 308
Read All
Int'l Clinical Service Expert

We are the leader
Because of our professionism