FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)
DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine h
Soligenix Completes Enrollment in its Pivotal Phase 3 Clinical Trial of SGX301 in the Treatment of Cutaneous T-cell Lymphoma
PRINCETON, N.J., Dec. 3, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to tr
FDA Approves Vyondys 53 (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53
CAMBRIDGE, Mass., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Ad
FDA Approves EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the First Generic NuvaRing
BRIDGEWATER, N.J.--(BUSINESS WIRE) December 12, 2019 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (AND
Dermavant Announces First Patient Dosed in Phase 2a Clinical Trial of Topical Dual JAK/Syk Inhibitor Cerdulatinib for Vitiligo
BASEL, Switzerland and LONG BEACH, Calif.—Dec. 3, 2019 — Dermavant Sciences, a dermatology-focused subsidiary of Roivant Sciences, today announced that the first patient has been dosed in its Phase 2a
Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Erosive Esophagitis
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec. 2, 2019 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel trea
FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and
FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelera
FDA Approves Exservan (riluzole) Oral Film for the Treatment of Amyotrophic Lateral Sclerosis
WARREN, N.J., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to sol
FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults
PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ -- SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to mark
FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 20, 2019 --Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (F
FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab
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