Saturday, March 30, 2019

Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients

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Allergan plc (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug A...
Friday, March 29, 2019

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

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     Harmony Biosciences, LLC (Harmony), announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New ...
Thursday, March 28, 2019

Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis

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    Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB)  announced that the U.S. Food and Drug Administration (FDA) has accepte...
Wednesday, March 27, 2019

Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

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    Bayer  announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administra...
Tuesday, March 26, 2019

FDA Approves Lonsurf (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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In continuation of my update on Lonsurf Taiho Oncology, Inc.  announced that the United States Food and Drug Administration (FDA) ha...
Saturday, March 23, 2019

FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares

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ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient n...
Friday, March 22, 2019

AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

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   In continuation of my update on  upadacitinib   AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has a...
Thursday, March 21, 2019

Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

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Gilead Sciences, Inc. (Nasdaq: GILD) announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating th...
Wednesday, March 20, 2019

Theravance Biopharma Announces First Patient Dosed in Registrational Phase 3 Study of Ampreloxetine (TD-9855) for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension

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 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company")  announced dosing of the first ...
Saturday, March 16, 2019

FDA Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis

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Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, announced  that the U.S. Food and Dr...
Friday, March 15, 2019

Researchers find clues that depression may speed brain aging

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In continuation of my updates on depression and its causes Memory and thinking skills naturally slow with age but now scientists are pe...
Thursday, March 14, 2019

Statins Help the Heart, No Matter What Your Age

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Cholesterol-lowering statins are already known to help cut heart risks for seniors and the middle-aged. Now, research confirms the me...
Wednesday, March 13, 2019

Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

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  Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Let...
Tuesday, March 12, 2019

Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application

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In continuation f my update on ALKS 5461   Alkermes plc (Nasdaq: ALKS) announced that it received a Complete Response Letter ...
Saturday, March 9, 2019

SK Life Science Announces FDA Acceptance of NDA Submission for Cenobamate, an Investigational Antiepileptic Drug

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   SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative biopharmaceutical company focused on developing a...