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FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced today that the U.S. Food and Drug Administration (FDA) approved Nexletol™ (bempedoic acid) tablet, an oral, once-da

Mycovia Pharmaceuticals Completes Enrollment in its Third Phase 3 Clinical Trial for VT-1161 (ultraVIOLET) in Patients with Recurrent Vulvovaginal Candidiasis

DURHAM, N.C.--(BUSINESS WIRE) December 18, 2019 -- Mycovia Pharmaceuticals, Inc. (“Mycovia”) today announced it has completed enrollment for its ongoing Phase 3 ultraVIOLET clinical trial for VT-1161.

Boehringer Ingelheim Discontinues Development of BI 1467335 for NASH

Ingelheim, Germany and Sydney, Australia, 18 December 2019 – Boehringer Ingelheim and Pharmaxis Ltd today announced the discontinuation of the development of BI 1467335 for the treatment of NASH (non-

Epizyme Announces FDA Advisory Committee Votes Unanimously in Favor of Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2019 -- Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the Oncologic Drugs

Biohaven Achieves Positive Topline Results in Pivotal Phase 2/3 Study of Vazegepant, the First and Only Intranasal CGRP Receptor Antagonist in Clinical Development for the Acute Treatment of Migraine

NEW HAVEN, Conn., Dec. 17, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive topline results from its randomized, dose ranging, placebo controlled

BioMarin Announces Positive Final Results from Placebo-Controlled Phase 3 Data in Children with Achondroplasia Treated with Vosoritide

SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today reported positive final results from its randomized, double-blind, placebo-controlled Phase 3 study

Pivotal DREAMM-2 Study Demonstrated a Clinically Meaningful Overall Response Rate with Belantamab Mafodotin (GSK2857916) for Patients with Relapsed/Refractory Multiple Myeloma

London, UK - December 16, 2019 -- GlaxoSmithKline today announced treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (OR

Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 17, 2019 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the ILLUMINATE-A Phase 3 study of lumasira

Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 16, 2019 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for d

Kura Oncology Receives Fast Track Designation for Tipifarnib in HRAS Mutant HNSCC and Provides Enrollment Guidance for AIM-HN Trial

SAN DIEGO, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cance

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food an

FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

DUBLIN--(BUSINESS WIRE)--Dec. 13, 2019 -- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Admini