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399 Result: FDA

UroViu Corporation's Single-Use Cystoscopy Platform Receives 2021 Product Innovation Award by Lucintel

April 06th, 2022

Dallas, TX / CRWE PRESS RELEASE / April 06, 2022 -- Based on recent research on the Single Use Endoscopy market, Lucintel is pleased to announce UroViu Corporation’s Cystoscopy Platform as the recipient of the “2021 Product Innovation Awa. Read more

Shire's First Prescription Eye Drop, Xiidra(TM) (lifitegrast ophthalmic solution) 5% Is Now Available in the U.S.

August 29th, 2016

Xiidra is the onlyprescription eye drop approved by the U.S. FDA for the treatment of both signs and symptoms of dry eye disease Resources are available to support patients seeking information regarding coverage and savings offers Xiidra is t. Read more

Trillium Therapeutics Receives FDA Clearance to Proceed With TTI-621 in Clinical Trial Targeting Solid Tumors and Mycosis Fungoides

August 17th, 2016

Toronto, Ontario / CRWE PRESS RELEASE / August 17, 2016 - Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, announced today that the US Food . Read more

Cesca Therapeutics Announces Promising Results From 40-Month Follow-Up of Patients Enrolled in Critical Limb Ischemia Feasibility Study

August 03rd, 2016

Rancho Cordova, Calif. / CRWE PRESS RELEASE / August 03, 2016 - Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced 40-month follow-up results for a number of patients that particip. Read more

Pluristem Receives Positive Feedback from FDA and Gears Up for Phase III Trial of PLX-PAD in Critical Limb Ischemia

August 02nd, 2016

- CLI is a severe unmet medical need whose treatment addresses a $12 billion global market - Multinational study to be conducted in U.S. and Europe - Estimated trial enrollment of approximately 250 patients - Primary endpoint for BLA will be time . Read more

Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

July 21st, 2016

LOS ANGELES, Calif. / CRWE PRESS RELEASE / July 21, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candida. Read more

ANI Pharmaceuticals Announces FDA Approval and Immediate Launch of Nilutamide Tablets, the First Generic Competitor to Nilandron(R)

July 18th, 2016

BAUDETTE, Minnesota / CRWE PRESS RELEASE / July 18, 2016 - ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) of the Abbreviated Ne. Read more

GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex(R) (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

June 27th, 2016

- Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo – - Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in Ma. Read more

GW Pharmaceuticals Announces New Planned Epidiolex (Cannabidiol or CBD) Development Program in Infantile Spasms (IS)

June 21st, 2016

London, UK / CRWE PRESS RELEASE / June 21, 2016 - GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics fr. Read more

Summit's Ridinilazole Preserves Microbiome During Treatment of C. Difficile Infection

June 20th, 2016

Microbiome-Sparing Action of Ridinilazole associated with Superiority over Vancomycin in Sustained Clinical Response Rate Oxford, UK / CRWE PRESS RELEASE / June 20, 2016- Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discove. Read more

VBI Vaccines Announces Medulloblastoma Immunotherapy Program

June 16th, 2016

Cambridge, Massachusetts / CRWE PRESS RELEASE / June 16, 2016 - VBI Vaccines Inc. (Nasdaq: VBIV and TSX: VBV) (“VBI”) today announced that it is developing a novel therapeutic vaccine candidate for medulloblastoma. The Meghan Rose Bradley. Read more

ANI Pharmaceuticals Announces FDA Approval of Oxcarbazepine Tablets

June 13th, 2016

BAUDETTE, Minnesota / CRWE PRESS RELEASE / June 13, 2016 - ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) of the Prior Approval. Read more

Shire Receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, Investigational Products for Rare Gastrointestinal Conditions

June 13th, 2016

Lexington, Mass. / CRWE PRESS RELEASE / June 13, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for two investigational products for r. Read more

Takeda to Present New Data at the American Diabetes Association's 76th Scientific Sessions

June 06th, 2016

Eight abstract presentations include new analyses from the EXAMINE trial and real-world databases Osaka, Japan / CRWE PRESS RELEASE / 6 June, 2016 – Takeda Pharmaceuticals Company Limited [TSE: 4502], (“Takeda”) will present eight. Read more

InVivo Therapeutics Reports Conversion of a Fourth Patient Implanted with the Neuro-Spinal Scaffold(TM) in the INSPIRE Study

April 26th, 2016

- Four Out of First Six Patients Have Converted from Complete to Incomplete Spinal Cord Injury – CAMBRIDGE, Mass. / CRWEPRESSRELEASE / April 26, 2016 – InVivo Therapeutics Holdings Corp. (NVIV) today announced that the sixth-implanted . Read more

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