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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

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

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

FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms
TOKYO, May 7, 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 approved a supplemental New Drug Application (sNDA) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 7, 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

Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT ® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
(Source: Johnson and Johnson)
Source: Johnson and Johnson - April 30, 2018 Category: Pharmaceuticals Source Type: news

Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT(R) (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Filing supported by data from MERIT-1 trial evaluating OPSUMIT in adults with inoperable CTEPH which showed significant improvements in pulmonary vascular resistance and six-minute walk distance (6MWD) compared with ongoing background therapy CHERRY HIL... Biopharmaceuticals, FDA Actelion Pharmaceuticals, Janssen, Johnson & Johnson, OPSUMIT, macitentan (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 30, 2018 Category: Pharmaceuticals 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

AcelRx receives positive CHMP opinion for DZUVEO(TM) for management of acute moderate to severe pain in medically monitored settings
DZUVEO is AcelRx's second developed sublingual sufentanil-based product to receive positive CHMP opinion, with Zalviso® already approved Resubmission of New Drug Application for DSUVIA™ (known as DZUVEO in Europe) to the FDA in the U.S. is planned f... Biopharmaceutical, Drug Delivery, Regulatory AcelRx Pharmaceuticals, DZUVEO, DSUVIA, sufentanil, sublingual (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 27, 2018 Category: Pharmaceuticals 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

Sage Therapeutics asks FDA to approve lead drug for postpartum depression
Cambridge-based Sage Therapeutics, one of the state ’s most valuable biotechs, said Monday that it had formally asked the FDA to approve its lead drug, a treatment for postpartum depression. The filing of a new drug application, or NDA, marks an important milestone for Sage (Nasdaq: SAGE), which has seen its share price soar over the past year tha nks largely to the success of brexanolone in late-stage trials. According to the company, the drug helped to reduce symptoms of depression among women… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 23, 2018 Category: American Health Authors: Max Stendahl 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

FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR(R)
COPENHAGEN, Denmark, April 20, 2018 -- (Healthcare Sales & Marketing Network) -- Veloxis Pharmaceuticals A/S announced today that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company's supplemental New Drug Application (s... Biopharmaceuticals, FDA Veloxis Pharmaceuticals, ENVARSUS, tacrolimus, kidney transplant (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 20, 2018 Category: Pharmaceuticals 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 enhances the transparency of clinical trials
Ashton Steinhagen, lead clinical research associate, IMARC When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic.  Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program. In t...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

In reversal, FDA accepts Alkermes ’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder for whom standard antidepressant therapies have not worked. Get the full story at our sister site, Drug Delivery Business News. The post In reversal, FDA accepts Alkermes’ depression drug for review appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat alkermes 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

Alembic Pharma gets USFDA nod for Acyclovir ointment
The company has received approval from the USFDA for its abbreviated new drug application (ANDA) Acyclovir ointment USP, 5 per cent, Alembic Pharmaceuticals said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 9, 2018 Category: Pharmaceuticals Source Type: news

Teligent, Inc. Announces FDA Approval of Ciclopirox Shampoo, 1%
BUENA, N.J., April 06, 2018 -- (Healthcare Sales & Marketing Network) -- Teligent, Inc. (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company’s abbreviated new drug application (... Biopharmaceuticals, Generics, FDA Teligent, Ciclopirox Shampoo, Ciclopirox (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 6, 2018 Category: Pharmaceuticals Source Type: news

Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
PARSIPPANY, N.J., April 06, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 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

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

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

Sunovion seeks FDA nod for sublingual film to treat Parkinson ’ s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As many as 60% of Parkinson’s patients have these kinds of episodes, according to the company. Get the full story at our sister site, Drug Delivery Business News. The post Sunovion seeks FDA nod...
Source: Mass Device - March 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Acorda Therapeutics Sunovion Pharmaceuticals Source Type: news

Catalyst Pharmaceuticals files new drug application with FDA
Catalyst Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration, bringing the Coral Gables-based drug maker one step closer to launching Firdapse, a treatment for a rare degenerative neuromuscular disease. Founded in 2002, Catalyst (Nasdaq: CPRX) has been working to develop Firdapse for almost a decade, a common timeline in the highly regulated pharmaceutical industry. Firdapse aims to treats symptoms of Lambert-Eaton myasthenic syndrome, a degenerative… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - March 29, 2018 Category: Health Management Authors: Debora Lima Source Type: news

Mesothelioma Clinical Trial Evaluating Selecta ’ s SEL-403 Begins
A clinical trial testing a new therapeutic modality on patients with pleural and peritoneal mesothelioma is officially underway. Selecta Biosciences, a clinical-stage biopharmaceutical company, and the National Cancer Institute (NCI) teamed up for the phase 1 clinical trial under the Cooperative Research and Development Agreement. The trial will evaluate safety and tolerability of SEL-403, Selecta’s investigational new drug combination consisting of a potent anti-tumor agent (LMB-100) and a drug that prevents an immune response (SVP-Rapamycin). LMB-100 and SVP-Rapamycin have been studied separately in clinical trials...
Source: Asbestos and Mesothelioma News - March 29, 2018 Category: Environmental Health Authors: Daniel King 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

Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Entecavir tablets (Baraclude(R))
BOCA RATON, Fla., March 27, 2018 -- (Healthcare Sales & Marketing Network) -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Entecavir ta... Biopharmaceuticals, Generics, FDA Breckenridge Pharmaceutical, Entecavir, Baraclude, hepatitis B virus (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 27, 2018 Category: Pharmaceuticals 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

Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
WHIPPANY, N.J., March 26, 2018 -- (Healthcare Sales & Marketing Network) -- Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO) has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and ... Biopharmaceuticals, Oncology, FDA Bayer, Loxo Oncology, larotrectinib, TRK Fusion Cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 26, 2018 Category: Pharmaceuticals Source Type: news

26.03.18: Not intended for U.S. and UK Media
Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancermehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - March 26, 2018 Category: Pharmaceuticals Source Type: news

Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancer (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - March 26, 2018 Category: Pharmaceuticals 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