CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
SEATTLE, Oct. 13, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration ( " FDA " or " the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 13, 2020 Category: Drugs & Pharmacology Source Type: news

Kadmon Announces Submission of New Drug Application to the U.S. FDA for Belumosudil in Patients with Chronic Graft-Versus-Host Disease
NEW YORK, NY / ACCESSWIRE / September 30, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for belumosudil... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 30, 2020 Category: Drugs & Pharmacology Source Type: news

BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A
SAN FRANCISCO, September 29, 2020– BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for fosdenopterin (previously... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2020 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
WARREN, N.J., Sept. 25, 2020 (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 - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
LAUSANNE, Switzerland--(BUSINESS WIRE)-- September 24, 2020 -- ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 24, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) September 22, 2020 -- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2020 Category: Drugs & Pharmacology Source Type: news

Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C
Copenhagen, Denmark, September 16, 2020– Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 16, 2020 Category: Drugs & Pharmacology Source Type: news

Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH
WALTHAM, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals,  Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company has submitted a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 15, 2020 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 14, 2020 Category: Drugs & Pharmacology Source Type: news

Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay (benzoyl peroxide) for the Treatment of Inflammatory Lesions of Rosacea
NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 10, 2020 Category: Drugs & Pharmacology Source Type: news

Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 1, 2020-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
ROCKLAND, Mass., Aug. 25, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2020 Category: Drugs & Pharmacology Source Type: news

Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2020 Category: Drugs & Pharmacology Source Type: news

Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 24, 2020-- Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 24, 2020 Category: Drugs & Pharmacology Source Type: news

BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
SAN RAFAEL, Calif., Aug. 20, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vosoritide, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 20, 2020 Category: Drugs & Pharmacology Source Type: news

BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
SAN RAFAEL, Calif., Aug. 19, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 19, 2020 Category: Drugs & Pharmacology Source Type: news

G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer
RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 17, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 12, 2020 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its NDA for Pedmark To Prevent Ototoxicity Associated With Cisplatin
RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2020 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
RESEARCH TRIANGLE PARK, N.C. USA, August 11, 2020– Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2020 Category: Drugs & Pharmacology Source Type: news

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury (remdesivir), an investigational... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Biogen ’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 7, 2020 Category: Drugs & Pharmacology Source Type: news

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma
PRINCETON, N.J.,& CAMBRIDGE, Mass.-- July 29, 2020 -- (BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 29, 2020 Category: Drugs & Pharmacology Source Type: news

scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission
BURLINGTON, Mass.--(BUSINESS WIRE)--Jul. 27, 2020-- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2020 Category: Drugs & Pharmacology Source Type: news

Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis
VICTORIA, British Columbia& ROCKVILLE, Md.--(BUSINESS WIRE) July 21, 2020 -- Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the“Company”), a late-stage clinical biopharmaceutical company focused on... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 21, 2020 Category: Drugs & Pharmacology Source Type: news

Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C
Copenhagen, Denmark, July 20, 2020– Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response in order to develop and commercialize novel therapeutics for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 20, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review to Merck ’s New Drug Application for Vericiguat
KENILWORTH, N.J.--(BUSINESS WIRE) July 16, 2020 -- 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 priority review the New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2020 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
DUBLIN, July 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 15, 2020 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, Pa., July 14, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 14, 2020 Category: Drugs & Pharmacology Source Type: news

ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis
MOUNTAIN VIEW, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) today confirmed that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer ’s Disease
CAMBRIDGE, Mass. and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed 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 - July 8, 2020 Category: Drugs & Pharmacology Source Type: news

Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
CAMBRIDGE, Mass., July 1, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2020 Category: Drugs & Pharmacology Source Type: news

scPharmaceuticals Announces Furoscix NDA Resubmission
BURLINGTON, Mass.--(BUSINESS WIRE)--Jul. 1, 2020-- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2020 Category: Drugs & Pharmacology Source Type: news

Mezzion Announces 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, June 30, 2020 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has 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 - June 30, 2020 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Provides Regulatory Update on VP-102
WEST CHESTER, Pa., June 29, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2020 Category: Drugs & Pharmacology Source Type: news

Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain
SAN DIEGO, June 29, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2020 Category: Drugs & Pharmacology Source Type: news