New Drug Applications Archive for 2017

January 4, 2017

• Ironwood Announces New Drug Application for Duzallo (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review

January 5, 2017

• Neurocrine Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia

January 6, 2017

• Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease

January 8, 2017

• AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain

January 9, 2017

• Alcobra Provides Update on Recent FDA Meeting and Path Forward for MDX Clinical Development Program

January 11, 2017

• U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab

January 13, 2017

• U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment

January 16, 2017

• Heron Announces Submission of Cinvanti NDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

January 18, 2017

• Ezra Announces FDA Acceptance of Filing of New Drug Application For EZR-104 for the Treatment of Hypertension and Heart Failure

January 19, 2017

• Symbiomix Therapeutics Submits New Drug Application to US FDA for Solosec for the Treatment of BV
• Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
• U.S. FDA Acknowledges Receipt of Shire’s New Drug Application for SHP465 for ADHD

January 23, 2017

• Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery

January 31, 2017

• OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375

February 2, 2017

• Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic
• U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

February 3, 2017

• Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for NDA for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets

February 7, 2017

• Flexion Therapeutics Announces NDA for Zilretta (FX006) Accepted by U.S. FDA

February 13, 2017

• Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen

February 21, 2017

• Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration
• The Medicines Company Announces FDA Filing Acceptance of New Drug Application for Intravenous Antibiotic Carbavance (meropenem-vaborbactam)

February 22, 2017

• Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery

February 27, 2017

• Aclaris Therapeutics Submits New Drug Application for A-101 as a Novel Treatment for Seborrheic Keratosis – a Common Skin Condition
• AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing
• Bausch + Lomb And Nicox Resubmit US New Drug Application For Novel Glaucoma Candidate Latanoprostene Bunod
• Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot® Testosterone

February 28, 2017

• FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review

March 1, 2017

• Aerie Pharmaceuticals Announces Resubmission of NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%

March 6, 2017

• Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes
• PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy

March 7, 2017

• FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation

March 9, 2017

• Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA

March 10, 2017

• Radius Health Receives Notification of PDUFA Extension for Abaloparatide-SC

March 17, 2017

• AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia

March 19, 2017

• Array BioPharma Announces Withdrawal of NDA for Binimetinib Monotherapy for the Treatment of NRAS-Mutant Melanoma

March 20, 2017

• Bausch + Lomb And Nicox Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene Bunod

March 23, 2017

• Symbiomix Therapeutics Announces FDA’s Acceptance of New Drug Application for Solosec with Priority Review Status

March 29, 2017

• Novartis Announces First CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with r/r B-Cell ALL Granted FDA Priority Review

March 30, 2017

• Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017

March 31, 2017

• Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL)

April 3, 2017

• Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia

April 4, 2017

• FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B

April 10, 2017

• TherapeuticsMD Provides TX-004HR Regulatory Update

April 11, 2017

• Nicox Announces PDUFA Date for Zerviate NDA

April 13, 2017

• Icon Bioscience Submits NDA For Dexycu, a Potential Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery

April 14, 2017

• FDA Issues Complete Response Letter for Baricitinib

April 17, 2017

• Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP
• Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

April 18, 2017

• Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL

April 19, 2017

• TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update

April 20, 2017

• PTC Therapeutics Completes Acquisition of Emflaza for the Treatment of Duchenne Muscular Dystrophy in the U.S.

April 25, 2017

• Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment

April 27, 2017

• Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States

April 28, 2017

• Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA

May 8, 2017

• TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application

May 9, 2017

• FDA Accepts Aclaris Therapeutics’ New Drug Application for Topical Treatment of Seborrheic Keratosis, a Common Skin Condition

May 15, 2017

• Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration
• Aerie Pharmaceuticals Announces FDA Acceptance of NDA Submission for Rhopressa (netarsudil ophthalmic solution) 0.02%

May 18, 2017

• Amgen Submits Biologics License Application to the FDA for Erenumab

May 23, 2017

• Churchill Pharmaceuticals Announces Submission of NDA for Yonsa (abiraterone acetate) Novel Oral Formulation of Prostate Cancer Treatment

May 24, 2017

• Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib
• Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab
• FDA Advisory Committee Recommends Approval of Endari from Emmaus Life Sciences for the Treatment of Sickle Cell Disease

May 26, 2017

• Sunovion Receives Complete Response Letter from FDA for SUN-101/eFlow® (glycopyrrolate) New Drug Application for Chronic Obstructive Pulmonary Disease (COPD)
• Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel

May 30, 2017

• Indivior Submits New Drug Application to U.S. FDA for RBP-6000 Buprenorphine Monthly Depot

May 31, 2017

• Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status

June 1, 2017

• EU and US Submissions for Single Tablet Combining Dolutegravir and Rilpivirine Priority Review Voucher Submitted in US with Anticipated Target Action Date of 6 Months

June 6, 2017

• Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy

June 12, 2017

• Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

June 19, 2017

• FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP

June 26, 2017

• Clarus Re-submits Jatenzo NDA Following Positive Results of inTUne Trial
• Kitov Updates on KIT-302 New Drug Application

June 27, 2017

• Agile Therapeutics Resubmits New Drug Application for its Transdermal Contraceptive Patch, Twirla

June 28, 2017

• Salix Announces Filing Acceptance for Plenvu Next Generation Bowel Cleansing Preparation for Colonoscopies

June 29, 2017

• Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)

June 30, 2017

• Aeterna Zentaris Resubmits NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults
• Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for SUN-101/eFlow® (glycopyrrolate) for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
• Steadymed Submits New Drug Application for Trevyent

July 6, 2017

• Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of PTSD

July 10, 2017

• Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors

July 11, 2017

• Ocular Therapeutix Receives Complete Response Letter from FDA for Dextenza NDA
• FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease

July 12, 2017

• FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer
• Novartis CAR-T Cell Therapy CTL019 Unanimously (10-0) Recommended for Approval by FDA Advisory Committee to Treat Pediatric, Young Adult r/r B-Cell ALL

July 16, 2017

• Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA

July 18, 2017

• NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date

July 20, 2017

• FDA Accepts Biologics License Application for Aimovig (erenumab)
• Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder
• Churchill Pharmaceuticals Announces NDA Filing Acceptance for Yonsa by the U.S. FDA
• Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin

July 25, 2017

• Lilly and Incyte Provide Update on Baricitinib

July 27, 2017

• Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla
• Aradigm Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis
• Advanced Accelerator Applications Completes Resubmission of NDA for Lutetium Lu 177 Dotatate (Lutathera) to FDA

July 28, 2017

• Dynavax Announces FDA Advisory Committee Vote in Favor of Heplisav-B

July 31, 2017

• Kitov Submits New Drug Application to FDA for KIT-302

August 2, 2017

• US FDA Accepts Regulatory Submission for Acalabrutinib and Grants Priority Review
• FDA Advisory Committee Does Not Recommend Approval of Sirukumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

August 3, 2017

• Dynavax Provides U.S. Regulatory Update on Heplisav-B Following FDA Advisory Committee Meeting

August 7, 2017

• Valeant Pharmaceuticals Receives Complete Response Letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA

August 9, 2017

• Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism

August 10, 2017

• Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV

August 14, 2017

• Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission

August 21, 2017

• Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder
• Cardiome Provides U.S. Regulatory Update for Brinavess

August 24, 2017

• Vertex Announces Acceptance of its Applications for Review of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis by the FDA and EMA
• Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab Biologics License Application in the US

August 25, 2017

• FDA Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome

August 28, 2017

• La Jolla Pharmaceutical Company Announces U.S. FDA Acceptance of New Drug Application for LJPC-501
• Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium Lu 177 Dotatate (Lutathera)

August 29, 2017

• Acorda Receives Refusal to File Letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) New Drug Application
• Apricus Biosciences Files NDA Resubmission for Vitaros
• Sorrento Therapeutics, Inc. Submits NDA For ZTlido Next-Generation Lidocaine Patch

August 30, 2017

• Lilly to File Baricitinib Resubmission to U.S. FDA Before End of January 2018

August 31, 2017

• SteadyMed Receives Refusal to File Letter from FDA for Trevyent New Drug Application
• Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD
• Akcea and Ionis Announce Submission of New Drug Application for Volanesorsen to the U.S. FDA

September 1, 2017

• Sanofi Receives Tentative FDA Approval of Admelog (insulin lispro injection) 100 units/mL

September 6, 2017

• AbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

September 12, 2017

• FDA Acknowledges Receipt of Sorrento Therapeutics Inc, NDA for ZTlido

September 13, 2017

• FDA Advisory Committee Votes Unanimously for Shingrix (HZ/su) in the US for Prevention of Herpes Zoster (Shingles) in Adults Ages 50 and Over

September 18, 2017

• Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder

September 19, 2017

• FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease

September 22, 2017

• Dova Pharmaceuticals Announces New Drug Application Submission to FDA for Avatrombopag, a Second Generation Thrombopoietin Receptor Agonist
• Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application

September 25, 2017

• Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status
• Janssen Submits NDA to U.S. FDA for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
• Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA

September 29, 2017

• INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA

October 2, 2017

• Kitov Announces Filing by FDA of New Drug Application for KIT-302
• Rigel Provides Update on FDA Review of Fostamatinib for ITP

October 10, 2017

• Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
• Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab Biologics License Application

October 11, 2017

• Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer

October 12, 2017

• AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA

October 13, 2017

• Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa (netarsudil ophthalmic solution) 0.02%

October 17, 2017

• Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA
• Charleston Laboratories, Inc. Resubmits NDA for CL-108

October 18, 2017

• Novo Nordisk Receives Positive 16-0 vote from FDA Advisory Committee in Favor of Approval for Semaglutide

October 19, 2017

• FDA Advisory Committee Unanimously Recommends Approval of Investigational Luxturna (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease

October 20, 2017

• Antares Pharma Receives Complete Response Letter From the FDA for Xyosted

October 25, 2017

• Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)
• PTC Therapeutics Receives Complete Response Letter for Ataluren's NDA

October 26, 2017

• Achaogen Submits Plazomicin New Drug Application (NDA) to the U.S. FDA for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections

October 27, 2017

• AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

October 30, 2017

• GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling NDA Submission to U.S. FDA for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome

October 31, 2017

• FDA Advisory Committees Recommend Approval of Indivior’s RBP-6000 for the Treatment of Opioid Use Disorder

November 1, 2017

• Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder

November 2, 2017

• Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection)
• Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-118, Novel Plaque Psoriasis Treatment
• Progenics Pharmaceuticals Completes Submission of NDA for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma

November 10, 2017

• Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

November 13, 2017

• Theravance Biopharma and Mylan Submit NDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

November 15, 2017

• Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS

November 16, 2017

• Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

November 20, 2017

• U.S. Food and Drug Administration (FDA) Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy

November 21, 2017

• U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine

November 27, 2017

• Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review

November 28, 2017

• Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab Biologics License Application
• GSK Submits US Regulatory Application for Single-Dose Tafenoquine for Plasmodium vivax Malaria

November 29, 2017

• TherapeuticsMD Announces Resubmission of New Drug Application for TX-004HR

December 6, 2017

• FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics

December 7, 2017

• Acorda Resubmits New Drug Application for Inbrija (CVT-301, levodopa inhalation powder)

December 8, 2017

• Sandoz Announces New Phase I Data Showing Proposed Biosimilar Pegfilgrastim Matches Reference Medicine
• SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission

December 11, 2017

• SIGA Technologies Announces FDA Submission of its New Drug Application for oral TPOXX (tecovirimat) to Treat Smallpox
• FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults

December 12, 2017

• Alnylam Completes Submission of New Drug Application to U.S. Food and Drug Administration (FDA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

December 14, 2017

• Amicus Therapeutics Submits New Drug Application to U.S. FDA for Migalastat for Treatment of Fabry Disease

December 18, 2017

• 60° Pharmaceuticals (60P) Submits New Drug Application to US FDA for Antimalarial Drug Tafenoquine
• FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

December 19, 2017

• TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR

December 20, 2017

• FDA Accepts New Drug Application for Seysara (sarecycline) for the Treatment of Moderate to Severe Acne
• Loxo Oncology Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancers
• Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

December 21, 2017

• Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea
• Santen Receives Complete Response Letter from U.S. FDA for Intravitreal Sirolimus (DE-109)

December 22, 2017

• Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy

December 26, 2017

• Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation

December 28, 2017

• TherapeuticsMD Announces Submission of New Drug Application for TX-001HR
• GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

December 29, 2017

• Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma