Acasti Pharma Inc., a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre for the treatment of severe hypertriglyceridemia, today announced that the two Phase 3 TRILOGY trials have now exceeded 65% patient randomization, and more than 100 patients have completed their
Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for its naloxone pre-filled single dose syringe product candidate. This injection is designed for the treatment of an opioid overdose. Dennis J. Carlo, President and CEO of Adamis, stated, This NDA submission rep
SAN DIEGO- Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for its fast-dissolving sublingual tadalafil tablet. This product candidate is designed for the treatment of erectile dysfunction. Dennis J. Carlo, President and Chief Executive Officer of Adamis, stated,'
After a strong 2017, biotech stocks are on track to end the year in the red despite a record 59 new molecular entity approvals, some noteworthy M&A deals and several breakthrough developments in drug discovery and research. The FDA on July 9 announced its acceptance of the NDA with priority review status, implying a six-month review period, renderi
A new therapy is giving new hope to researchers who treat non-small cell lung cancer, a new study says. Researchers at the University of Colorado Cancer Center studied 110 patients, 83 percent of whom never smoked but all tested positive for the gene ALK. "What this shows is that with the development of good targeted therapies for ALK-positive lun
SEATTLE- CTI BioPharma Corp. announced today the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib. These forward-looking statements include statements regarding our expectations regarding anticipated interactions with regulators, our ability to establish a dose for our randomized Phase 3 study of pacritinib, t
Enzychem Lifesciences, Corp. is a global biopharmaceutical company headquartered in Seoul, Korea, which is dedicated to developing new drugs and APIs. Since its foundation in 1999, Enzychem Lifesciences has been striving to develop new and innovative treatments capable of addressing unmet medical needs with R&D-driven approaches under its grand...
The Food and Drug Administration has approved focused ultrasound as a treatment for a symptom of Parkinson's disease, opening up the pioneering treatment for widespread use. Studies at the University of Virginia, which partners with the Charlottesville- based Focused Ultrasound Foundation, laid the groundwork for the approval. The approval was base
Heron Therapeutics, Inc., a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration has accepted the new drug application for Heron's investigational agent, HTX-011,
The global intracranial pressure monitoring devices market 2019-2023 is expected to post a CAGR of close to 7% during the forecast period, according to the latest market research report by Technavio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181231005080/en/.
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that Justin Gover, GW s Chief Executive Officer, will present a company update at the J.P. About GW Pharmaceuticals plc and Greenwich Biosciences, Inc..
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss new drug application 210934 for sotagliflozin oral tablet, sponsored by Sanofi-Aventis U.S. LLC, for the proposed indication: Adjunct to insulin therapy to improve glycemic control in adul
Heron Therapeutics, Inc. (NASDAQ:HRTX) Files An 8-K Financial Statements and ExhibitsItem 9.01 HERON THERAPEUTICS, INC. /DE/ ExhibitEX-99.1 2 d675951dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 FDA Grants Priority Review Designation for Heron Therapeutics? NDA for HTX-011,?To view the full exhibit click here About Heron Therapeutics, Inc. (NASDAQ:HRT
On December 31, 2018, Heron Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration accepted for review, and granted a Priority Review designation for, the Company's New Drug Application for the investigational agent HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a
We expect LY03004 will be launched in the U.S. and China markets by the end of 2019. ". Moreover, registration of Rivastigmine single-day transdermal patch has already been accepted by National Medicine Products Administration in China. The registrations of above products are progressing well in strategic markets such as China, the U.S., Europe and
Two commercial products have already been approved and marketed by the Company's licensees JCR Pharmaceuticals Co, Ltd. in Japan and Takeda Pharmaceutical Company in Europe. Mesoblast has one product candidate which has successfully completed Phase 3 and with near-term commercial potential in the United States, another product candidate having...
Onconova Therapeutics, Inc., a Phase 3- stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, today announced that Management will meet Investors and potential partners at the 2019 China Focus event, and during the 37 th Annual J.P. Morgan Healthcar
Portola Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved the Company s Prior Approval Supplement for its large-scale, second generation Andexxa , allowing for broad commercial launch in the United States. Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was i
A shorter week than normal due to holidays doesn t mean one without important news especially with the US Food and Drug Administration open. This past week, Horizon Pharma announced its supplemental new drug application was approved by the FDA, meaning it can expand the age range for RAVICTI. Dova Pharmaceuticals Sesen Bio Adaptimmune Therape
Senate Bill 2341 classifies synthetic substances as dangerous Schedule I drugs if they haven't beed approved by the U.S. Food and Drug Administration or aren't being dispensed or possessed in accordance with state or federal law. Synthetic pot, often marketed as "K2" or "spice," is made by spraying chemicals on dried plant material or sold as a liq
Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for its fast-dissolving sublingual tadalafil tablet. This product candidate is designed for the treatment of erectile dysfunction. Dennis J. Carlo, President and Chief Executive Officer of Adamis, stated, The fil
The FDA has granted Fast Track Designation to BioXcel Therapeutics BXCL501 for the treatment of acute agitation resulting from neurological and psychiatric disorders like Alzheimers and schizophrenia. BioXcel is a clinical-stage biopharmaceutical development company utilising novel artificial intelligence approaches to identify new candidate...
Bridge Biotherapeutics Inc, a clinical stage biotech company headquartered in Seongnam, South Korea has announced that the company has successfully activated clinical study sites for the Phase 2 study of BBT-401, a drug candidate for Ulcerative Colitis treatment. "We are very excited to initiate the Phase 2 study following the successful first-in-
Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea, announced that the company has successfully activated clinical study sites for the Phase 2 study of BBT-401, a drug candidate for Ulcerative Colitis treatment. "We are very excited to initiate the Phase 2 study following the successful first-in-hu
CTI BioPharma Corp. announced today the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib. The Company expects to report the determination of the optimal dose of pacritinib in mid-2019 following a meeting with the U.S. Food and Drug Administration. Topline efficacy and safety data are expected in the third quar