FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion
LAVAL, Quebec, June 18, 2018 /PRNewswire/ -- Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 18, 2018 Category: Drugs & Pharmacology Source Type: news

Motif Bio Submits NDA for Iclaprim
NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 14, 2018 Category: Drugs & Pharmacology Source Type: news

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)
MARLBOROUGH, Mass.--(BUSINESS WIRE) June 12, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 12, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
June 7, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company ’s New Drug Application for talazoparib. The submission is based on results... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
NEW YORK, June 06, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of a rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 6, 2018 Category: Drugs & Pharmacology Source Type: news

Evoke Announces FDA Submission of New Drug Application for Gimoti
SOLANA BEACH, Calif., June 04, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the submission of its 505(b)(2) New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA
CRANBURY, N.J., June 4, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application
Oxford, UK – 1 June 2018 Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug Application (NDA) to the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab
Tokyo, Japan, May 30, 2018 –Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and COO: Masashi Miyamoto, “Kyowa Hakko Kirin”) announced today that it has been notified that the U.S. Food and Drug Administration (FDA) is extending its review... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
WHIPPANY, N.J., May 29, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by its collaboration partner Loxo Oncology, Inc. (NASDAQ: LOXO), and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 29, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
TOKYO, May 29, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. " Astellas " ) announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 29, 2018 Category: Drugs & Pharmacology Source Type: news

Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder
Plymouth Meeting, Pa. —May 28, 2018 — Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2018 Category: Drugs & Pharmacology Source Type: news

AcelRx Announces FDA Acceptance of NDA for DSUVIA
REDWOOD CITY, Calif., May 24, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

Teva Confirms September PDUFA Date for Fremanezumab
JERUSALEM--(BUSINESS WIRE)--May 23, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
PHOENIX, May 22, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
BRIDGEWATER, N.J. and THE WOODLANDS, Texas, May 22, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis
MAHWAH, N.J., May 21, 2018 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food& Drug Administration (FDA) for its leading... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy
PRINCETON, N.J., May 18, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq:AGRX), a women's healthcare company, today announced the content of the official minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
DURHAM, N.C.--(BUSINESS WIRE)--May 15, 2018-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes in Favor of Waylivra (volanesorsen) for Treatment of Familial Chylomicronemia Syndrome
CAMBRIDGE, Mass. and CARLSBAD, Calif., May 10, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2018 Category: Drugs & Pharmacology Source Type: news

AcelRx Resubmits New Drug Application for DSUVIA
REDWOOD CITY, Calif., May 9, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 9, 2018 Category: Drugs & Pharmacology Source Type: news

Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration
SALT LAKE CITY, May 9, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, announced today that it has received a Complete Response Letter ( " CRL " ) from the United States Food and Drug Administration ( " FDA " )... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 9, 2018 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice
STAINES-UPON-THAMES, United Kingdom, May 3, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today expressed disappointment that, in a joint meeting, the U.S. Food and Drug Administration's... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections
SOUTH SAN FRANCISCO, Calif., May 02, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 2, 2018 Category: Drugs & Pharmacology Source Type: news

SIGA Technologies Announces Favorable Outcome of Advisory Committee In Support of TPOXX
NEW YORK, May 01, 2018 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
PARIS and TARRYTOWN, N.Y., April 30, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 30, 2018 Category: Drugs & Pharmacology Source Type: news

AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 25, 2018 Category: Drugs & Pharmacology Source Type: news

Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia
TOKYO, April 23, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, April 23, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 23, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the Company has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Pfizer Granted FDA Breakthrough Therapy Designation for Trumenba (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
Monday, April 23, 2018 - Pfizer Inc. (NYSE: PFE) today announced that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
LONDON and CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ( “GW”, “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 19, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Grants Breakthrough Therapy Designation For Genentech ’s Hemlibra (emicizumab-kxwh) in Hemophilia A Without Inhibitors
South San Francisco, CA -- April 16, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 16, 2018 Category: Drugs & Pharmacology Source Type: news

Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
DUBLIN, April 16, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461, a novel, once-daily, oral investigational... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 16, 2018 Category: Drugs & Pharmacology Source Type: news

AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
NORTH CHICAGO, Ill., April 10, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
BOSTON--(BUSINESS WIRE)--Apr. 9, 2018-- Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 9, 2018 Category: Drugs & Pharmacology Source Type: news

Antares Pharma Provides Xyosted Regulatory Update
EWING, N.J., April 05, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) (the Company) today announced that the U.S. Food and Drug Administration (FDA or the Agency) acknowledged receipt of the Company ’s March 29, 2018 resubmission to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 5, 2018 Category: Drugs & Pharmacology Source Type: news

Antares Pharma Provides Xyosted (testosterone enanthate subcutaneous injection) Regulatory Update
EWING, N.J., April 05, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) (the Company) today announced that the U.S. Food and Drug Administration (FDA or the Agency) acknowledged receipt of the Company ’s March 29, 2018 resubmission to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 5, 2018 Category: Drugs & Pharmacology Source Type: news

Paratek ’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA
BOSTON, April 04, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 4, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
April 4, 2018 - Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company ’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 4, 2018 Category: Drugs & Pharmacology Source Type: news

US FDA Accepts Biologics License Application for Moxetumomab Pasudotox in Hairy Cell Leukemia
April 3, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 3, 2018 Category: Drugs & Pharmacology Source Type: news

Alkermes Receives Refusal to File Letter From FDA for ALKS 5461
DUBLIN, April 2, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461, a once-daily, oral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 2, 2018 Category: Drugs & Pharmacology Source Type: news

Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome
CORAL GABLES, Fla., March 29, 2018 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms
LOUISVILLE, Ky., March 27, 2018 /PRNewswire/ -- US WorldMeds today announced that the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine for mitigating opioid... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 27, 2018 Category: Drugs & Pharmacology Source Type: news

Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes
The Woodlands, Texas, March 26, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2018 Category: Drugs & Pharmacology Source Type: news

Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancer
STAMFORD, Conn., March 26, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2018 Category: Drugs & Pharmacology Source Type: news

Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
CRANBURY, N.J., March 26, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 26, 2018 Category: Drugs & Pharmacology Source Type: news

Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131)
NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53
CAMBRIDGE, Mass., March 12, 2018 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 12, 2018 Category: Drugs & Pharmacology Source Type: news