Small Molecules

05 Feb 2019 FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam, and Supplemental NDA (sNDA) for ZERBAXA® (Ceftolozane and Tazobactam)
04 Feb 2019 Verseon Reports First Dosing in Phase 1 Trial on New Precision Oral Anticoagulant
04 Feb 2019 SK life science announces FDA acceptance of NDA submission for cenobamate, an investigational antiepileptic drug
04 Feb 2019 Neurana Pharmaceuticals Announces First Patient Enrolled in the "STAR Study," a Phase 2 Dose Ranging Study of Tolperisone in Acute Muscle Spasms of the Back
04 Feb 2019 Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis
04 Feb 2019 Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
04 Feb 2019 Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society’s Conference: Advances in Sleep and Circadian Science
02 Feb 2019 Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
01 Feb 2019 Achillion Announces First Dosing in Phase 1 Multiple Ascending Dose Study of ACH-5228 Next-Generation Oral Factor D Inhibitor in Healthy Volunteers
01 Feb 2019 FDA Expands Lilly's ALIMTA® (pemetrexed) Label with Combination of KEYTRUDA® (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer
01 Feb 2019 Hua Medicine Initiates First Combination Study of Dorzagliatin with a DPP-4 Inhibitor in the United States
01 Feb 2019 OPKO Provides Update on the Development of OPK-88004, a Selective Androgen Receptor Modulator
31 Jan 2019 Cullinan Oncology to Develop Novel EBNA1 Inhibitor Discovered by The Wistar Institute
31 Jan 2019 Deinove is preparing initiation of Phase II for DNV3837 in Clostridium difficile infections, with a key partner
31 Jan 2019 Sanofi: Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of Congo
30 Jan 2019 Janssen Announces ERLEADA® (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer
30 Jan 2019 Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy
29 Jan 2019 Spero Therapeutics Announces Initiation of SPR720 Phase 1 Clinical Trial
29 Jan 2019 Allakos Announces Positive Phase 2 Results in Patients with Cholinergic Urticaria and Symptomatic Dermographism
29 Jan 2019 Theravance Biopharma Announces First Patient Dosed in Registrational Phase 3 Study of Ampreloxetine (TD-9855) for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension
29 Jan 2019 Nicox Announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis
29 Jan 2019 AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) - First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patien
25 Jan 2019 Clovis Oncology Announces European Commission Authorization of Rubraca®▼ (rucaparib) Tablets as Maintenance Treatment for Women with Relapsed Ovarian Cancer
24 Jan 2019 Concert Pharmaceuticals Initiates Phase 1 Single-Ascending Dose Trial of CTP-692 as an Adjunctive Treatment for Schizophrenia
24 Jan 2019 X-Rx Announces FDA Acceptance of IND Application for X-165

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