FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the treatment of Wilson ’s Disease
NDA supported by positive data from Phase 3 CHELATE clinical trial TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease Paris, France– 02 September 2021 – Orphalan SA, a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 2, 2021 Category: Drugs & Pharmacology Source Type: news

Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2021 Category: Drugs & Pharmacology Source Type: news

Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 25, 2021-- Moderna, Inc. (Nasdaq:... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing titers against the wild-type strain one month... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
BOSTON, Aug. 24, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 24, 2021 Category: Drugs & Pharmacology Source Type: news

Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
NEW YORK, Aug. 23, 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 - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 17, 2021 Category: Drugs & Pharmacology Source Type: news

Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
Paris (France), Friday 13 August, 2021– Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2021 Category: Drugs & Pharmacology Source Type: news

Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis
LONG BEACH, Calif.& BASEL, Switzerland--(BUSINESS WIRE) August 10, 2021 --Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2021 Category: Drugs & Pharmacology Source Type: news

Dar é Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis
SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 9, 2021 Category: Drugs & Pharmacology Source Type: news

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim)
HENDERSON, Nev.--(BUSINESS WIRE)--Aug. 6, 2021-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 6, 2021 Category: Drugs & Pharmacology Source Type: news

Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update
RADNOR, Pa.--(BUSINESS WIRE)--August 3, 2021 -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 3, 2021 Category: Drugs & Pharmacology Source Type: news

GSK Files for Licensure of Priorix MMR Vaccine in the US
August 2, 2021 -- GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Priorix (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval for use in active... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 2, 2021 Category: Drugs & Pharmacology Source Type: news

Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
FREMONT, Calif. and WALTHAM, Mass., July 29, 2021 /PRNewswire/ -- Ardelyx Inc.,(Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Application for Genentech ’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
South San Francisco, CA -- July 28, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA),... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
 DURHAM, N.C.--(BUSINESS WIRE) July 28, 2021 --Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, July 26, 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... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Braeburn ’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.– June 26, 2021– Braeburn announces that the New Drug Application (NDA) for Brixadi (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 26, 2021 Category: Drugs & Pharmacology Source Type: news

Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease
16 July 2021 -- The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

Tezepelumab Granted Priority Review By U.S. FDA
THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 7, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Levo Therapeutics ’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
RED BANK, N.J., July 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Filing of Hutchmed ’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Hong Kong, Shanghai& Florham Park, NJ— Thursday, July 1, 2021: Hutchmed (China) Limited (“Hutchmed”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 28, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a 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 - June 28, 2021 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film
WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 24, 2021 Category: Drugs & Pharmacology Source Type: news

Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 24, 2021-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 24, 2021 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark
Research Triangle Park, NC, June 22, 2021– Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 22, 2021 Category: Drugs & Pharmacology Source Type: news

Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
CAMBRIDGE, Mass., June 21, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

Orphazyme Provides Regulatory Update from FDA on Arimoclomol for Niemann-Pick Disease Type C
Copenhagen – June 18, 2021 – Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced it has received a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 18, 2021 Category: Drugs & Pharmacology Source Type: news

Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis
WILMINGTON, Del.--(BUSINESS WIRE) June 11, 2021 -- Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 11, 2021 Category: Drugs & Pharmacology Source Type: news

Adamis Provides Update on Zimhi
SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s resubmitted New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 9, 2021 Category: Drugs & Pharmacology Source Type: news

Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis
LONG BEACH, Calif., and BASEL, Switzerland, June 3, 2021—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 3, 2021 Category: Drugs & Pharmacology Source Type: news

BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN)
NEW YORK, June 01, 2021 (GLOBE NEWSWIRE)— BeyondSpring Inc. (the“Company” or“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

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

Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)
PARIS, FRANCE, 28 May 2021– Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– May 28, 2021 (GLOBE NEWSWIRE)– Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 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