Tag: FDA
Huntington Study Group Welcomes FDA Approval of New Drug for Chorea...
Rochester, NY August 18, 2023 --(PR.com)-- The Huntington Study Group (HSG) together with its wholly owned subsidiary, HSG Clinical Research, Inc., a world...
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment …...
The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults...
SystImmune, Inc. Announces FDA Clearance of IND Application for BL-B01D1, a...
REDMOND, Wash., July 1, 2023 /PRNewswire/ -- SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA)...
Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1...
IND demonstrates Drug Farm's leadership in ALPK1, representing the Company's second ALPK1 program to enter clinical development
Drug Farm announced today the U.S. Food...
Biotech Executive Michael Smith Discusses the FDA Drug Development Process with...
LEHI, Utah, June 16, 2023 (GLOBE NEWSWIRE) -- CancerVAX, Inc., developer of a breakthrough universal cancer vaccine that uses the body's...
U.S. FDA approves Bylvay® for patients living with cholestatic pruritus...
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021...
U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Preventi…...
PREVYMIS now approved for CMV prophylaxis after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients
Merck MRK, known as MSD outside of the United States...
FDA Roundup: May 19, 2023 – Press Release
SILVER SPRING, Md., May 19, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from...
Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials...
NEW YORK, April 29, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today...
ANI Pharmaceuticals Announces the FDA Approval and Launch of Nitrofurantoin Oral…...
ANI Pharmaceuticals, Inc. (ANI or the Company) ANIP today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated...