CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis
SEATTLE, June 1, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
DURHAM, N.C.--(BUSINESS WIRE) June 01, 2021 -- Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark
Research Triangle Park, NC, May 28, 2021– Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 25, 2021 Category: Drugs & Pharmacology Source Type: news

BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II
NEW HAVEN, Conn., May 19, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ( " BioXcel " or the " Company " ) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 19, 2021 Category: Drugs & Pharmacology Source Type: news

Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA for the Treatment of Opioid Overdose
SAN DIEGO, May 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2021 Category: Drugs & Pharmacology Source Type: news

Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing ’s Syndrome
DUBLIN, Ireland and TREVOSE, Pa., May 13, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2021 Category: Drugs & Pharmacology Source Type: news

Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2021 Category: Drugs & Pharmacology Source Type: news

Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
MORRISVILLE, N.C., May 10, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7, 2021, it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2021 Category: Drugs & Pharmacology Source Type: news

Clearside Biomedical Announces Resubmission of New Drug Application for Xipere for Treatment of Macular Edema Associated with Uveitis
ALPHARETTA, Ga., May 03, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2021 Category: Drugs & Pharmacology Source Type: news

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer
CAMBRIDGE, Mass.& OSAKA, Japan--(BUSINESS WIRE) April 27, 2021-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 27, 2021 Category: Drugs & Pharmacology Source Type: news

Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome
PLANO, Texas, April 26, 2021 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the“Company,” or“we”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 26, 2021 Category: Drugs & Pharmacology Source Type: news

Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
NEW YORK, April 26, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 26, 2021 Category: Drugs & Pharmacology Source Type: news

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021– Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 9, 2021 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
NEW YORK--(BUSINESS WIRE) April 07, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
SEATTLE, March 31, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application ( " NDA " ) submission to the U.S. Food and Drug Administration ( " FDA " ) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2021 Category: Drugs & Pharmacology Source Type: news

Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 30, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 30, 2021 Category: Drugs & Pharmacology Source Type: news

Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 29, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced today that its New Drug Application (NDA) for maralixibat, an oral apical sodium dependent bile acid transporter (ASBT) inhibitor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 29, 2021 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 29, 2021 Category: Drugs & Pharmacology Source Type: news

Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
SEOUL, South Korea, March 28, 2021 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2021 Category: Drugs & Pharmacology Source Type: news

Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain
NEW YORK AND INDIANAPOLIS, March 25, 2021—Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 25, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb ’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
PRINCETON, N.J.--(BUSINESS WIRE)-- March 19, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 19, 2021 Category: Drugs & Pharmacology Source Type: news

Merck Receives Priority Review From FDA for New Drug Application for HIF-2 α Inhibitor Belzutifan (MK-6482)
KENILWORTH, N.J.--(BUSINESS WIRE) March 16, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 16, 2021 Category: Drugs & Pharmacology Source Type: news

Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy
Mar 15, 2021 -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 15, 2021 Category: Drugs & Pharmacology Source Type: news

BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the“Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 11, 2021 Category: Drugs & Pharmacology Source Type: news

Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
RALEIGH, N.C., March 11, 2021– Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the Kyzatrex® New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 11, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts the New Drug Application for Review of Idorsia ’s Daridorexant for the Treatment of Adult Patients with Insomnia
Allschwil, Switzerland– March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia’s investigational dual orexin receptor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 10, 2021 Category: Drugs & Pharmacology Source Type: news

Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
NEW YORK, NY / ACCESSWIRE / March 10, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 10, 2021 Category: Drugs & Pharmacology Source Type: news

Vifor Pharma and Cara Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for Korsuva Injection in Hemodialysis Patients With Moderate-to-Severe Pruritus
St.Gallen, Switzerland, and Stamford, Conn., 8 March 2021–Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced  that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 8, 2021 Category: Drugs & Pharmacology Source Type: news

Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
PRINCETON, N.J., March 02, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing ’s Syndrome to the FDA
DUBLIN, Ireland and TREVOSE, Pa., March 02, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

Eyenovia Announces FDA Acceptance of the MydCombi NDA
NEW YORK--(BUSINESS WIRE)--Mar. 2, 2021-- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Merck ’s Gefapixant New Drug Application for Review
KENILWORTH, N.J.--(BUSINESS WIRE) March 1, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Reata Pharmaceuticals, Inc. Submits NDA for Company ’s Lead Program: Bardoxolone in Alport Syndrome
PLANO, Texas, March 01, 2021 (GLOBE NEWSWIRE)— Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the“Company,” or“we”), a clinical-stage biopharmaceutical company, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia
NORTH CHICAGO, Ill., Feb. 25, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 25, 2021 Category: Drugs & Pharmacology Source Type: news

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis
WILMINGTON, Del.--(BUSINESS WIRE) February 19, 2021 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2021 Category: Drugs & Pharmacology Source Type: news

Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
COPENHAGEN, Denmark and BOTHELL, Wash.; Feb 10, 2021– Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 10, 2021 Category: Drugs & Pharmacology Source Type: news

Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients
ROCKVILLE, Md., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 8, 2021 Category: Drugs & Pharmacology Source Type: news

Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 1, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 1, 2021 Category: Drugs & Pharmacology Source Type: news

Biogen and Eisai Announce FDA ’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 29, 2021 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat
BOSTON, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance of New Drug Application for INP104 for the Acute Treatment of Migraine
SEATTLE, January 20, 2021— Impel NeuroPharma, a late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s 5O5(b)(2) New Drug Application (NDA) for INP104... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 20, 2021 Category: Drugs & Pharmacology Source Type: news

Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism
Raleigh, N.C., Jan. 5, 2021— Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2021 Category: Drugs & Pharmacology Source Type: news

US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
 NEW YORK& MIAMI--(BUSINESS WIRE) Monday, January 04, 2021 -- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2021 Category: Drugs & Pharmacology Source Type: news

Provention Bio Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals
RED BANK, N.J., Jan. 4, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 29, 2020 Category: Drugs & Pharmacology Source Type: news