Tag Archives: Approves

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer Print this page November 2, 2018 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer… Read More »

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta Print this page REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients… Read More »

FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause

FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause Print this page BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 29, 2018– TherapeuticsMD, Inc, an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Bijuva (estradiol and progesterone) capsules, 1 mg/100… Read More »