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

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

Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi
NEW YORK--(BUSINESS WIRE)--Dec. 29, 2020-- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 29, 2020 Category: Drugs & Pharmacology Source Type: news

Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
STAMFORD, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2020 Category: Drugs & Pharmacology Source Type: news

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Hong Kong, Shanghai,& Florham Park, NJ: Monday, December 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2020 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– Dec. 23, 2020 (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 - December 23, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda ’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
Osaka, JAPAN, December 15, 2020– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted for review the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 15, 2020 Category: Drugs & Pharmacology Source Type: news

Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection ( " Flesh-Eating Disease " )
DURHAM, N.C. and NESS ZIONA, Israel, Dec. 10, 2020 /PRNewswire/ -- Atox Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted to file the New Drug Application (NDA) for reltecimod with a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 10, 2020 Category: Drugs & Pharmacology Source Type: news

Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC
BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it has submitted a New Drug Application (NDA) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2020 Category: Drugs & Pharmacology Source Type: news

Lipocine Announces Tentative Approval of TLANDO
SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/— Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2020 Category: Drugs & Pharmacology Source Type: news

Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris
NESS ZIONA, Israel, Dec. 07, 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 - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix
BURLINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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 - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
DURHAM, N.C., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
JERSEY CITY, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc.,  (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 3, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the Company has initiated a rolling 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 - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma
PALO ALTO, CA– December 1, 2020– BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

Kadmon Announces FDA Acceptance of NDA for Belumosudil in Patients With Chronic Graft-Versus-Host Disease
NEW YORK, NY / ACCESSWIRE / November 30, 2020 / Kadmon Holdings, Inc. (NASDAQ:KDMN) 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 - November 30, 2020 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, Nov. 30, 2020 (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 - November 30, 2020 Category: Drugs & Pharmacology Source Type: news

Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
RESEARCH TRIANGLE PARK, N.C., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia Corporation (NASDAQ: LQDA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 25, 2020 Category: Drugs & Pharmacology Source Type: news

CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
Berkeley Heights, NJ– November 18, 2020 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 18, 2020 Category: Drugs & Pharmacology Source Type: news

Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review
DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2020 Category: Drugs & Pharmacology Source Type: news

Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH
WALTHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals,  Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 16, 2020 Category: Drugs & Pharmacology Source Type: news

Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding Zimhi
SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 16, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease
PARIS– November 13, 2020 - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 13, 2020 Category: Drugs & Pharmacology Source Type: news

Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain
SAN DIEGO, Nov. 13, 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 - November 13, 2020 Category: Drugs & Pharmacology Source Type: news

Supernus Provides Regulatory Update for SPN-812
ROCKVILLE, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts BioMarin's New Drug Application for Vosoritide to Treat Children with Achondroplasia
SAN RAFAEL, Calif., Nov. 2, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vosoritide, an investigational,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2020 Category: Drugs & Pharmacology Source Type: news

Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta
FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, announced today that it has received a complete response letter (CRL) from the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 21, 2020 Category: Drugs & Pharmacology Source Type: news

Scynexis Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection
JERSEY CITY, N.J., Oct. 14, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the submission... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 14, 2020 Category: Drugs & Pharmacology Source Type: news

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

FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 9, 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