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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

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

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

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

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

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

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

FDA Expands Authorized Use of REGEN-COV (casirivimab and imdevimab)

TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (