FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

South San Francisco, CA -- September 4, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavre

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Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that detailed Phase 3 results of evinacumab were presented today as a late-breaking presentatio

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FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

PRINCETON, N.J.--(BUSINESS WIRE) September 1, 2020 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets,

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FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair

ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ -- Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug

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FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency

Plainsboro, NJ, Aug 28, 2020 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10

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FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

Lainate, Italy – August 27, 2020 – Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of ac

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FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis

Basel, August 20, 2020 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the trea

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FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder

South San Francisco, CA -- August 14, 2020 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the

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FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy Print this page

PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ -- NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne

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FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older

South San Francisco, CA -- August 7, 2020 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi (risdiplam) for treatment of

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FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain

CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with cen

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FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children

WHIPPANY, N.J.--(BUSINESS WIRE) August 7, 2020 -- Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from b

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