04/21/21 4:45 PMNasdaq : KMPHKemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS(TM) Per License Agreement with Affiliate of Gurnet Point CapitalKemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, todayRHEA-AIvery positive
04/21/21 8:00 AMNYSE : MDTMedtronic Receives U.S. FDA Approval for Pipeline(TM) Flex Embolization Device with Shield Technology(TM)Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and DrugRHEA-AIneutral
04/21/21 7:30 AMOTC : BPSROrganicell Announces FDA Approval Of IND Application For The Use Of Zofin(TM) In The Treatment Of OsteoarthritisOrganicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its leadRHEA-AIneutral
04/20/21 1:30 AMNasdaq : ERPYERYTECH Requested a Pre-BLA Meeting with the FDA to Discuss Path to Approval in ALLERYTECH Requested a Pre-BLA Meeting with the FDA to Discuss Path to Approval in ALL ERYTECH invited by FDA to request a pre-BLA meeting F irst step in the marketing approval process with the FDA for eryaspase for the treatment of hypersensitive ALL patients based on the positive results of theRHEA-AIvery positive
04/19/21 7:08 AMNasdaq : CTSOU.S. FDA Approves CytoSorbents to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic SurgeryCytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb (R) blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that theRHEA-AIvery positive
04/13/21 5:42 PMNasdaq : GILDU.S. FDA Grants Accelerated Approval to Trodelvy(R) for the Treatment of Metastatic Urothelial CancerGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (R) (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received aRHEA-AIpositive
04/13/21 7:00 AMNasdaq, OTC : MEIP, KYKOYMEI Pharma and Kyowa Kirin Announce Completion of Patient Enrollment in Follicular Lymphoma Primary Efficacy Population of Global Phase 2 TIDAL Study Intended to Support Potential Accelerated Approval Application from U.S. Food and Drug Administration (FDA)MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, and Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new valueRHEA-AIvery positive
04/13/21 1:00 AMOTC : RHHBYFDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications? Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment Basel, 13 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approvedRHEA-AIvery positive
04/12/21 1:20 PMOTC : RHHBY FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All IndicationsGenentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application for Xolair (R) (omalizumab) prefilled syringe for self-injection across all approved U.S.RHEA-AIvery positive
04/12/21 1:00 AMOTC : CMOPFCosmo announces FDA approval of GI Genius(TM) intelligent endoscopy module, its revolutionary Artificial Intelligence device for lesion detection during colonoscopyCosmo Pharmaceuticals NV (SIX: COPN) today announced the FDA approval of GI Genius(TM) intelligent endoscopy system, its revolutionary device for lesion detection during colonoscopy.The GI Genius module FDA approval marks a pivotal milestone for Cosmo afterRHEA-AIvery positive
04/09/21 3:00 PMNasdaq : SRNE Scilex Holding, a Subsidiary of Sorrento, Has Received From FDA a sNDA Approval for ZTlido(R) Label ExpansionScilex Holding ("Scilex"), an over 99% owned subsidiary of Sorrento Therapeutics (NASDAQ: SRNE, "Sorrento"), has received a supplemental new drug application (sNDA) approval from the FDA for ZTlido(R) to make efficacy labeling change withRHEA-AIneutral
04/08/21 4:05 PMNasdaq : KMPHKemPharm Announces Amendment to Licensing Agreement with Gurnet Point Capital Affiliate Following FDA Approval of AZSTARYS(TM)Amendment Increases Total Potential Regulatory and Sales Milestone Payments to $590 Million, and Adds a New Top-Level Tier for Royalties on U.S. Net Sales Conference Call and Live Audio Webcast Scheduled for Today, Thursday, April 8, at 4:30 p.m. ET CELEBRATION, Fla., April 08, 2021 (GLOBERHEA-AIvery positive
04/08/21 2:30 PMOTC : OPTIOptec Receives First Shipment of Home Use FDA Approved Rapid Antigen Test KitsOPTEC International, Inc. (OTC Pink:OPTI), a developer of UV and UV-C safety products using related advanced technologies specific to Personal Protection Equipment (PPE), announced the company today received the first shipment of FDA approved Antigen HomeRHEA-AIvery positive
04/08/21 7:30 AMOTC : COPRFCollection Sites Makes Affordable FDA EUA Approved COVID-19 At-Home Testing Available NationwideMedivolve Inc.RHEA-AIneutral
04/07/21 7:53 PMNasdaq : GILDFDA Approves Trodelvy(R), the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall SurvivalGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy (R) (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received twoRHEA-AIpositive
04/07/21 7:30 AMNYSE : BHCFDA Approves Bausch + Lomb ClearVisc(TM) Dispersive Ophthalmic Viscosurgical DeviceBausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), today announced that the U.S. Food and DrugRHEA-AIneutral
04/06/21 4:03 PMNasdaq : NUVANuVasive's Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc ReplacementNuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify (R) Cervical Artificial Disc (Simplify Disc)RHEA-AIvery positive
04/06/21 7:05 AMNasdaq : TMDXTransMedics Stock Trading Halted Today; FDA Advisory Committee to Review Premarket Approval Application for the OCS Heart SystemTransMedics Group, Inc. ("TransMedics") (NASDAQ: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today that Nasdaq has halted trading of theRHEA-AIneutral
04/02/21 4:58 PMNasdaq : SUPNSupernus Announces FDA Approval of Qelbree(TM) (SPN-812) for the Treatment of ADHDSupernus Pharmaceuticals, Inc. (Nasdaq: SUPN), aRHEA-AIvery positive
04/01/21 6:00 AMNasdaq : UTHRUnited Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung DiseaseUnited Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved Tyvaso (R) (treprostinil) Inhalation Solution for the treatment of patients with pulmonaryRHEA-AIpositive
03/31/21 6:13 PMNasdaq : SNYFDA approves Sarclisa(R) (isatuximab-irfc) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myelomaThe U.S. Food and Drug Administration (FDA) has approved Sarclisa (R) (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to threeRHEA-AIneutral
03/31/21 4:11 PMNYSE : INSPInspire Medical Systems, Inc. Announces FDA Approval and Commercial Launch of New Physician Programmer PlatformInspire Medical Systems, Inc. (NYSE: INSP) ("Inspire"), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today announced receiptRHEA-AIvery positive
03/31/21 3:40 AMNasdaq : BFRABiofrontera submits application for FDA approval of new BF-RhodoLED(R) XL lampBiofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapyRHEA-AIvery positive
03/30/21 6:15 PMNasdaq : JAZZJazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos(R) (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric PatientsJazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos (R) (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloidRHEA-AIneutral
03/30/21 8:05 AMNasdaq : GHGuardant Health Receives ADLT Status from CMS for FDA-Approved Guardant360(R) CDx Test Guardant Health, Inc. (Nasdaq: GH) announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 (R) CDx test. The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutationRHEA-AIvery positive
03/30/21 8:00 AMNasdaq : IMABI-Mab and ABL Bio Receive US FDA Approval to Initiate Phase 1 Trial of Bispecific Antibody TJ-CD4B/ABL111 in Patients with Advanced or Metastatic Solid TumorsI-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the development of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing inRHEA-AIvery positive
03/30/21 7:30 AMNasdaq : MBRXMoleculin Receives FDA Approval of Fast Track Designation for Annamycin in the Treatment of Sarcoma Lung MetastasesMoleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug AdministrationRHEA-AIvery positive
03/29/21 6:00 AMNasdaq : AMPHAmphastar Pharmaceuticals Receives FDA Approval for Dextrose InjectionAmphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration ("FDA") approved the Company's Abbreviated New Drug Application ("ANDA") for Dextrose injection 50% in the 50 mL Luer-Jet (R) PrefilledRHEA-AIvery positive
03/29/21 6:00 AMOTC : CYDYThe Philippines FDA Approves the Use of Leronlimab to Treat a COVID-19 PatientCytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix(TM) (leronlimab-PRO 140), a CCR5RHEA-AIvery positive
03/26/21 1:34 PMNYSE : MDTMedtronic Receives FDA Approval for "Breakthrough" Transcatheter Pulmonary Valve Replacement for Patients with Congenital Heart DiseaseMedtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for its Harmony(TM) Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy created to treatRHEA-AIpositive
03/24/21 3:30 AMOTC : EPWCFEmpower Clinics KAI Medical Laboratory Participates In U.S. Federal Government RFP Bids To Test In Excess Of 50,000 Employees Using FDA Approved KAI Saliva COVID-19 At Home PCR TestEMPOWER CLINICS INC. (CBDT:CSE)RHEA-AIvery positive
03/23/21 8:53 AMNasdaq : ORMPOramed Initiates Second Phase 3 Oral Insulin Study Under the FDA's Approved Dual Concurrent ProtocolOramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ( www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has screened the first patients in its ORA-D-013-2 study, theRHEA-AIneutral
03/23/21 8:51 AMNasdaq : ORMPOramed Initiates Second Phase 3 Oral Insulin Study Under the FDA's Approved Dual Concurrent ProtocolOramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ( www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has screened the first patients in its ORA-D-013-2 study, theRHEA-AIneutral
03/23/21 6:45 AMNYSE : MRKFDA Approves Merck's KEYTRUDA(R) (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) CarcinomaMerck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ)RHEA-AIneutral
03/23/21 6:00 AMOTC : GWHPGlobal WholeHealth Partners, Corp (OTC:GWHP) Secures Global Distribution Rights to Sell the AstraZeneca COVID-19 Vaccine Anywhere in the World Pending FDA Approval as Biden Administration Stockpiles VaccineGlobal WholeHealth Partners Corp, (OTC PINK:GWHP) a multinational supplier of over 70+ FDA approved tests including Dengue, Ebola, Zika, Malaria also offering one of the largest lines of tests for CoViD19 SARS2, is prepared to help in the fightRHEA-AIneutral
03/22/21 6:42 PMNasdaq : PCRXPacira Announces FDA Approval of Supplemental New Drug Application for EXPAREL(R) (bupivacaine liposome injectable suspension) in Pediatric PatientsPacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment toRHEA-AIpositive
03/22/21 5:50 PMNasdaq : ZEALZealand Pharma Announces FDA Approval of Zegalogue(R) (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with DiabetesCompany announcement - No. 16 / 2021 Zealand Pharma Announces FDA Approval of Zegalogue (R) (dasiglucagon) injection, for the Treatment of Severe Hypoglycemia in People with Diabetes Zegalogue will be available in both an auto injector and a prefilled syringe for the treatment of severe hypoglycemiaRHEA-AIneutral
03/18/21 4:30 PMNasdaq : KNSAKiniksa Announces FDA Approval of ARCALYST (R) (rilonacept) for Recurrent Pericarditis- ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis - - Commercial launch expected in April 2021 - - Kiniksa launches Kiniksa One Connect(TM) patient support program - - Conference call and webcast scheduled for 5:30 p.m. EDT today - HAMILTON, Bermuda, March 18, 2021RHEA-AIvery positive
03/18/21 7:00 AMNYSE : BSXBoston Scientific Receives FDA Approval for TheraSphere(TM) Y-90 Glass MicrospheresBoston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere(TM) Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). TheRHEA-AIvery positive
03/17/21 6:30 AMOTC : GWHPGlobal WholeHealth Partners Corp (OTC:GWHP) Secures Global Distribution Rights to Sell the AstraZeneca COVID-19 Vaccine Anywhere in the World Pending FDA Approval as Biden Administration Stockpiles VaccineGlobal WholeHealth Partners Corp. (OTC:GWHP), a multinational supplier of over 70+ FDA approved tests including Dengue, Ebola, Zika, Malaria and also offering one of the largest lines of tests for CoViD19 SARS2, is preparedRHEA-AIneutral
03/16/21 9:56 PMNasdaq, NYSE : HUGEFSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases in Dogs and CatsFSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) ("FSD Pharma" or the "Company") today announces that it has entered into a license agreement (the "License Agreement") with Innovet Italia S.R.L. ("Innovet"), under which Innovet granted the Company a license to use ultramicronized-palmitoylethanolamideRHEA-AIvery positive
03/16/21 8:25 AMNasdaq : ORMPOramed Reaches 25% Randomization in World's First Phase 3 Oral Insulin Study Conducted Under FDA Approved ProtocolOramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) ( www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has enrolled and randomized 25% of the 675 patients planned for itsRHEA-AIneutral
03/15/21 4:05 PMNYSE : INSPInspire Medical Systems, Inc. Announces FDA Approval of Two-Incision Implant ProcedureInspire Medical Systems, Inc. (NYSE: INSP) ("Inspire"), a medical technology company focused on the development and commercialization of innovative and minimallyRHEA-AIvery positive
03/15/21 7:00 AMNasdaq : CHEKCheck-Cap Receives FDA IDE Approval for Pivotal Study of C-Scan(R)Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan (R), the first and only patient-friendly, preparation-free, screening test to detect polypsRHEA-AIneutral
03/11/21 9:00 AMNasdaq : LGVNLongeveron's Lomecel-B(TM) Approved by FDA for Compassionate Use for the Treatment of Child with Hypoplastic Left Heart Syndrome (HLHS)Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food & Drug Administration (FDA) hasRHEA-AIpositive
03/10/21 3:25 PMNasdaq : AVEOAVEO Oncology Announces U.S. FDA Approval of FOTIVDA(R) (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and Drug Administration (FDA) has approved FOTIVDA (R) (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. FOTIVDA is an oral,RHEA-AIvery positive
03/09/21 1:00 AMOTC : RHHBYRoche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatmentRHEA-AIvery positive
03/08/21 6:59 AMNasdaq : VTRSViatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort(R) (budesonide/formoterol fumarate dihydrate) Inhalation AerosolViatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version ofRHEA-AIvery positive
03/05/21 7:49 PMNasdaq : GILDU.S. FDA Approves Yescarta(R) for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic TherapyKite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta (R) (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines ofRHEA-AIvery positive
03/05/21 8:30 AMOTC : CSLLYSeqirus Announces U.S. FDA Approval of Expanded Age Indication of Its Cell-Based Quadrivalent Influenza Vaccine for People Two Years of Age and OlderSeqirus, a global leader in influenza prevention, today announced that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX (R) QUADRIVALENT (Influenza Vaccine), the company's cell-based quadrivalent influenza vaccine (QIVc), for an expandedRHEA-AIneutral
