New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Cytalux (pafolacianine) Injection for Identification of Ovarian Cancer During Surgery

November 29 2021

WEST LAFAYETTE, Ind., Nov. 29, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and...

FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Disease

November 23 2021

- In the Phase 3 SOLSTICE study, more than twice the proportion of adult transplant recipients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ at Week 8 with Livtencity (56%; n=131/235), compared to...

FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)

November 23 2021

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance LOS ANGELES, Nov. 23, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc....

FDA Approves Voxzogo (vosoritide) to Increase Linear Growth in Children with Achondroplasia

November 19 2021

SAN RAFAEL, Calif., Nov. 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Voxzogo™ (vosoritide) for Injection, indicated...

FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

November 18 2021

Keytruda Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions Keytruda Is the First Immunotherapy...

FDA Approves Besremi (ropeginterferon alfa-2b-njft) for the Treatment of Adults With Polycythemia Vera

November 12 2021

BURLINGTON, Mass.--(BUSINESS WIRE) November 12, 2021 --PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology...