Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA
THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 12, 2018 Category: Drugs & Pharmacology Source Type: news

Roche announces submission of supplemental New Drug Application for Venclexta for people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy
Roche today announced submission of a supplemental New Drug Application (sNDA) to the United States (U.S.) Food and Drug Administration (FDA) for Venclexta  (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. (Source: Roche Investor Update)
Source: Roche Investor Update - July 12, 2018 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA's tentative nod for Deferasirox tablets
The group now has 202 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 7, 2018 Category: Pharmaceuticals Source Type: news

Theratechnologies Submits Novel Single-Vial Formulation of EGRIFTA(R) (Tesamorelin for Injection) for FDA Approval
MONTREAL, July 04, 2018 -- (Healthcare Sales & Marketing Network) -- Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced that it has filed a supplemental new drug application (sNDA) with the Food and Drug Administration (FDA) for a single-v... Biopharmaceuticals, HIV/AIDS, FDA Theratechnologies, EGRIFTA, Tesamorelin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 4, 2018 Category: Pharmaceuticals Source Type: news

Ocular Therapeutix resubmits NDA for ocular pain relief implant
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA. The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time. Get the full story at our sister site, Drug Delivery Business News. The post Ocular Therapeutix resubmits NDA for ocular pain relief implant appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat oculartherapeutix Source Type: news

FDA Grants Priority Review for Pfizer ’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia
June 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company ’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2018 Category: Drugs & Pharmacology Source Type: news

Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER
AUSTIN, Texas, June 26, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA grants Priority Review to Roche ’s baloxavir marboxil for the treatment of influenza
Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older. (Source: Roche Investor Update)
Source: Roche Investor Update - June 26, 2018 Category: Pharmaceuticals Source Type: news

IMBRUVICA(R) (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer
The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus rituximab may improve outcomes across all lines of Waldenström's macroglobulinemia (WM) treatment, including patients with prior lines of therapy and variou... Biopharmaceuticals, Oncology, FDA AbbVie, IMBRUVICA, ibrutinib, Waldenström's Macroglobulinemia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 25, 2018 Category: Pharmaceuticals Source Type: news

USFDA approves first product from Glenmark's US plant
The US Food and Drug Administration has provided its first supplemental Abbreviated New Drug Application approval for the company's plant in Monroe, Glenmark (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 19, 2018 Category: Pharmaceuticals Source Type: news

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

FDA rejects Mylan ’s generic Advair again
Mylan announced that the FDA will not approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline's asthma drug, Advair Diskus, due to “minor deficiencies” in the application. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 15, 2018 Category: Pharmaceuticals 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

Alembic Pharma gets USFDA nod for its antibiotic capsules
The approval from USFDA is for the company's abbreviated new drug application (ANDA) in the strengths of 50 mg and 100 mg, Alembic Pharma said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 14, 2018 Category: Pharmaceuticals Source Type: news

FDA to review Sunovion ’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29. Get the full story at our sister site, Drug Delivery Business News. The post FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals Sunovion Pharmaceuticals 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

FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS ® (carfilzomib) Label
KYPROLIS, Lenalidomide and Dexamethasone Extended Median Overall Survival in Relapsed or Refractory Multiple Myeloma Patients to 48 Months KYPROLIS is the First and Only Treatment to Demonstrate Overall Survival Benefits in Two Phase 3 Studies in Relapsed or Refractory Multiple Myeloma THOUSAND OAKS, Calif., June 11, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (car...
Source: Amgen News Release - June 11, 2018 Category: Pharmaceuticals Tags: Uncategorized 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

Glenmark Pharmaceuticals gets USFDA nod for contraceptive drugs
The company's current portfolio consists of 137 products authorised for distribution at the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. (Source: The Economic Times)
Source: The Economic Times - June 6, 2018 Category: Consumer Health News 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

Alembic Pharma plans Rs 720-crore capex for FY19
The pharma firm has filed 12 ANDAs (abbreviated new drug applications) during the March quarter, taking the total filings in FY18 to 26. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 3, 2018 Category: Pharmaceuticals Source Type: news

Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated
PHILADELPHIA, June 1, 2018 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Levoflo... Biopharmaceuticals, Generics, FDA, Product Launch Lannett Company, Janssen Pharmaceuticals, Levofloxacin, Levaquin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 1, 2018 Category: Pharmaceuticals 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

FDA halts Vertex, CRISPR sickle-cell trial
CRISPR Therapeutics and Vertex Pharmaceuticals announced that the U.S. FDA has placed a clinical hold on the new-drug application for a drug used for the treatment of sickle-cell disease. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 1, 2018 Category: Pharmaceuticals Source Type: news

Sage Therapeutics wins priority review for intravenous postpartum depression drug
Sage Therapeutics (NSDQ:SAGE) said today that the FDA accepted its new drug application for an intravenous formulation of brexanolone as a treatment for postpartum depression. The application was accepted under priority review status, according to the Cambridge, Mass.-based company. If approved, the drug would be the first therapy specifically indicated to treat postpartum depression – the most common medical complication of childbirth. Get the full story at our sister site, Drug Delivery Business News. The post Sage Therapeutics wins priority review for intravenous postpartum depression drug appeared first on M...
Source: Mass Device - May 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat sagetherapeutics 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 -- (Healthcare Sales & Marketing Network) -- 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 R... Biopharmaceuticals, Oncology, FDA Astellas Pharma, gilteritinib, Acute Myeloid Leukemia, FLT3 (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 29, 2018 Category: Pharmaceuticals Source Type: news

29.05.18: Not intended for U.S. and UK Media
U.S. FDA accepts larotrectinib New Drug Application and grants priority reviewmehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - May 29, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA accepts larotrectinib New Drug Application and grants priority review (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - May 29, 2018 Category: Pharmaceuticals 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

FDA rejects Recro Pharma new drug application for a non-opioid pain medicine
The Food and Drug Administration rejected a new drug application submitted by Recro Pharma for its new drug candidate, a non-opioid pain medicine. The action sent the Malvern specialty pharmaceutical company's stock plunging by more than 50 percent to $6.14 in pre-market trading. In the complete response letter the FDA sent to Recro Pharma (NASDAQ: REPH), the FDA said it is unable to approve the application for IV meloxicam in its current f orm. IV Meloxicam is an intravenous formulation of an oral… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 24, 2018 Category: American Health Authors: John George 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

King of Prussia biopharm firm posts positive study data for experimental pneumonia therapy
Nabriva Therapeutics announced positive results Monday from its second large-scale, late-stage clinical trial of its experimental therapy for community-acquired bacterial pneumonia (CABP). The biopharmaceutical company, which has operations in Dublin, Ireland and King of Prussia, plans to file a new drug application for the therapy – called Lefamulin – with the Food and Drug Administration during the fourth quarter of this year. Nabriva’s stock surged by more than 20 percent in pre-market… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - May 21, 2018 Category: Biotechnology Authors: John George 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

Karl Storz Focuses on Bladder Cancer Detection With New Device
Karl Storz is focusing on bladder cancer detection with its latest product. The El Segunda, CA-based company said it is launching the PDD Blue Light Flexible Video Cytoscopy System. The product launch follows the approval of a supplemental new drug application and a premarket approval supplement from FDA extending the indication for Blue Light Cystoscopy with Cysview (BLCC) to include use of the new Karl Storz PDD Blue Light Flexible Video Cystoscope. Also included in the approval is an expanded indication for the repetitive use of Cysview within the same patient and for the identification of Carcinoma in Situ (CIS); one o...
Source: MDDI - May 18, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business 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

FDA is asking for more information on application forms: Here ’s why that’s good for innovation and improving health
Christopher Leptak, M.D., Ph.D., is Director, Office of New Drug’s Regulatory Science Program in the FDA’s Center for Drug Evaluation and Research. By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT....
Source: Mass Device - May 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice 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

UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients
Atlanta, Georgia (U.S.)& Brussels (Belgium), 0700 CEST, 14 May, 2018: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company ’s newest anti-epileptic drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 14, 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