Food and Drug Administration (FDA) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Biogen Plans Regulatory Filing for Aducanumab in Alzheimer ’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies
CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that, after consulting with the U.S. Food and Drug Administration (FDA), Biogen plans to pursue regulatory... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 22, 2019 Category: Pharmaceuticals Source Type: clinical trials

[Fam-] Trastuzumab Deruxtecan Granted FDA Priority Review for Treatment of Patients with HER2-positive Metastatic Breast Cancer
17 October 2019 -- AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 17, 2019 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
OSAKA, Japan& FLORHAM PARK, N.J.–(BUSINESS WIRE) October 16, 2019 -- Shionogi& Co., Ltd. (hereafter“Shionogi”) today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 16, 2019 Category: Pharmaceuticals Source Type: clinical trials

AstraZeneca Announces FDA Complete Response Letter Regarding NDA for PT010 in COPD
October 1, 2019 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 1, 2019 Category: Pharmaceuticals Source Type: clinical trials

Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis
MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 30, 2019 Category: Pharmaceuticals Source Type: clinical trials

FDA Accepts Merck ’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus
KENILWORTH, N.J.--(BUSINESS WIRE)-- September 17, 2019 -- Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 17, 2019 Category: Pharmaceuticals Source Type: clinical trials

Novartis Investigational Lung Cancer Therapy Capmatinib (INC280) Granted FDA Breakthrough Therapy Designation for Patients with MET-Mutated Advanced Non-Small Cell Lung Cancer
Basel, September 6, 2019 – " We are pleased to announce that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 6, 2019 Category: Pharmaceuticals Source Type: clinical trials

Janssen Announces U.S. FDA Breakthrough Therapy Designation for Investigational Prophylactic Vaccine for the Prevention of Respiratory Syncytial Virus in Older Adults
LEIDEN, Netherlands– September 3, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 3, 2019 Category: Pharmaceuticals Source Type: clinical trials

Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial
DiscussionThe TRITON trial aims to assess the effect of ondansetron across multiple centres. By defining ondansetron ’s mechanisms of action we hope to better identify patients with IBS-D who are likely to respond.Trial registrationISRCTN,ISRCTN17508514, Registered on 2 October 2017. (Source: Trials)
Source: Trials - August 19, 2019 Category: Research Source Type: clinical trials

Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo ® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
August 01, 2019 -- Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 1, 2019 Category: Pharmaceuticals Source Type: clinical trials

Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration(FDA), the company provided an... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 1, 2019 Category: Pharmaceuticals Source Type: clinical trials

FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis
NEW YORK (June 6, 2019)—TB Alliance announced today that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted (14 yes, 4 no, 0 abstain) that there is substantial evidence of the effectiveness and sufficient... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 6, 2019 Category: Pharmaceuticals Source Type: clinical trials

Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Tokyo and Basking Ridge, NJ– (May 14, 2019)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the outcome of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) to discuss... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 14, 2019 Category: Pharmaceuticals Source Type: clinical trials

FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo ’s Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor
Tokyo and Basking Ridge, NJ– (May 14, 2019)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (Vote: 12 yes, 3... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 14, 2019 Category: Pharmaceuticals Source Type: clinical trials

TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 15, 2019 Category: Pharmaceuticals Source Type: clinical trials