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FDA Approves Gavreto for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM
Natera Announces SMART Study Data for Aneuploidy and 22q Unblinded
Aimmune Agrees to be Acquired by Nestlé Health Science for $2 Billion
Twist Bioscience Announces Potent SARS-CoV-2 Neutralizing Data from COVID-19 Therapeutic Antibody Program
Final Analysis of the Observational GioTag Study: Sequential Afatinib and Osimertinib in Patients with EGFR Mutation-Positive NSCLC
Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications
FDA Approves Onureg, a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
FDA Accepts Vertex’s sNDA for Trikafta, Symdeko and Kalydeco for Additional CFTR Mutations
Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for Novel Immunotherapy Program

Tag Archives: Letairis

October, 2015

5 October
FDA Approves Gilead’s Letairis with Tadalafil for Treatment of PAH

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 2, 2015– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Letairis® (ambrisentan) in combination with tadalafil for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to …
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April, 2015

6 April
Actavis Seeks US Approval to Market Generic Version of Gilead’s PAH Drug

Dublin-based Actavis PLC said Friday that it is seeking approval from the US Food and Drug Administration (FDA) to sell a generic version of Gilead Sciences Inc.’s pulmonary arterial hypertension (PAH) drug. The company confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the agency seeking approval …
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