01/20/21 6:45 AMNYSE : MRKMerck Announces U.S. FDA Approval of VERQUVO(R) (vericiguat)Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved VERQUVO, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following aRHEA-AIneutral
01/15/21 5:30 PMNasdaq : HALOHalozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO(R) (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) AmyloidosisHalozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (R) (daratumumab and hyaluronidase-fihj) in combination with bortezomib,RHEA-AIpositive
01/14/21 4:30 PMNYSE : PFEPfizer's XALKORI(R) (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young AdultsPfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI (R) (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplasticRHEA-AIpositive
01/12/21 9:00 AMNasdaq : LMNLLiminal BioSciences Receives FDA Approval for its US-based Plasma Collection CenterLAVAL, QC and CAMBRIDGE, England, Jan. 11, 2021 - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, announced that the Company's wholly-owned subsidiary, Prometic Plasma Resources ( USA) Inc., has received U.S.RHEA-AIvery positive
01/08/21 8:00 AMNYSE : AMRXAmneal Launches Generic Abiraterone Acetate Tablets, USP, 500 mg, Following ANDA Approval by FDAAmneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA), from the U.S. Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, USP, 250 mg and 500 mg.RHEA-AIneutral
01/05/21 8:00 AMNYSE : CURRCURE Pharmaceutical Receives FDA Approval for its IND Application for Erectile Dysfunction Product CUREfilm Blue(TM)CURE Pharmaceutical Holding Corp. ("CURE" or the "Company") (OTC: CURR), a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved anRHEA-AIpositive
12/28/20 8:00 AMNasdaq : CNSPCNS Pharmaceuticals Featured in Syndicated Broadcast Covering Recent FDA Approval of IND Applicationvia InvestorWire - CNS Pharmaceuticals, Inc . (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces that it has beenRHEA-AIvery positive
12/23/20 4:05 PMNasdaq : UROVUrovant Sciences Announces U.S. FDA Approval of GEMTESA(R) (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA(R) (vibegron), a beta-3 adrenergic receptor (?3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urgeRHEA-AIneutral
12/21/20 7:10 AMNasdaq : LEGNLegend Biotech Announces Initiation of Rolling Submission of Biologics License Application to U.S. FDA Seeking Approval of BCMA CAR-T Therapy Cilta-cel for the Treatment of Relapsed and/or Refractory Multiple MyelomaLegend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the initiation of a rolling submission of a Biologics LicenseRHEA-AIvery positive
12/20/20 7:00 PMNasdaq : KPTIAntengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO(R) (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior TherapyAntengene Corporation Limited ("Antengene", SEHK: 6996.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq:RHEA-AIpositive
12/18/20 5:49 PMNYSE : TAKU.S. FDA Approves Supplemental New Drug Application for Takeda's ICLUSIG(R) (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CMLTakeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG (R) (ponatinib) for adult patients with chronic-phase (CP) chronic myeloid leukemia (CML) with resistanceRHEA-AIpositive
12/18/20 4:49 PMNYSE : MYOVMyovant Sciences Announces FDA Approval of ORGOVYX(TM) (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate CancerMyovant Sciences (NYSE: MYOV), a healthcareRHEA-AIvery positive
12/18/20 11:30 AMNasdaq : KPTIKaryopharm Announces FDA Approval of XPOVIO(R) (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior TherapyKaryopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved XPOVIO(R) (selinexor), the Company's first-in-class,RHEA-AIvery positive
12/17/20 4:52 PMNYSE : ABTFDA Approves Labeling Update for Abbott's HeartMate 3 Heart Pump for use in Pediatric PatientsAbbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company's HeartMate 3(TM) heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With theRHEA-AIneutral
12/17/20 4:05 PMNasdaq : CNSPCNS Pharmaceuticals Announces Call to Discuss FDA IND Approval and Phase 2 Trial for BerubicinCNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will host aRHEA-AIneutral
12/17/20 4:00 PMNasdaq : AMGNFDA Approves Amgen's RIABNI(TM) (rituximab-arrx), A Biosimilar To Rituxan(R) (rituximab)Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI(TM) (rituximab-arrx), a biosimilar to Rituxan (R) (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), ChronicRHEA-AIpositive
12/17/20 9:00 AMNasdaq : CNSPCNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate BerubicinCNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that theRHEA-AIneutral
12/17/20 8:59 AMNYSE : GSKFDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the USGlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a seriousRHEA-AIvery positive
12/16/20 8:15 PMNasdaq : ZLABZai Lab Partner MacroGenics Announces FDA Approval of MARGENZA(TM) for Patients with Pretreated Metastatic HER2-Positive Breast CancerMARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin(R) ( trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial MARGENZA is approved, in combination with chemotherapy, for the treatment ofRHEA-AIpositive
12/16/20 4:30 PMNasdaq : MGNXMacroGenics Announces FDA Approval of MARGENZA(TM) for Patients with Pretreated Metastatic HER2-Positive Breast CancerMARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin(R) ( trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial MARGENZA is approved, in combination with chemotherapy, for the treatment ofRHEA-AIpositive
12/15/20 7:00 AMNasdaq : ATNXAthenex Announces FDA Approval of Klisyri(R) (Tirbanibulin) for the Treatment of Actinic Keratosis on the Face or ScalpKlisyri (R) is the first FDA approved proprietary product for Athenex First-in-class microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) on the face or scalp with a 5-day application course Klisyri will be manufactured by Athenex Almirall will launch Klisyri in theRHEA-AIvery positive
12/14/20 3:15 PMNYSE : RO, ROG, RHHBYFDA Approves Genentech's Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple SclerosisGenentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus (R) (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multipleRHEA-AIneutral
12/10/20 8:30 AMNasdaq : ENTXEntera Bio Announces FDA Approval of IND Application for EB613 - an Oral Human Parathyroid Hormone (1-34) for the Treatment of OsteoporosisEntera Bio Ltd. (NASDAQ: ENTX), a leader inRHEA-AIneutral
12/10/20 8:28 AMNASDAQ : VIVEViveve Announces FDA Approval of Proposed Amendments to Pivotal U.S. PURSUIT Trial ProtocolViveveRHEA-AIpositive
12/08/20 4:30 PMNasdaq : ALBOAlbireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC- Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients - - EMA grants accelerated assessment , validates Marketing Authorization Application for odevixibat with o rphan d esignation and access to PRIority MEdicines (PRIME) - - FDA has granted o devixibat F ast T rack,RHEA-AIvery positive
12/04/20 9:33 PMNYSE : NVOFDA approves Saxenda(R) for the treatment of obesity in adolescents aged 12-17Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda (R) (liraglutide) injection 3 mg for use in the treatment of obesity in adolescents (12-17 years) with a body weight above 60 kg and anRHEA-AIneutral
12/03/20 8:45 PMNasdaq : BCRXBioCryst Announces FDA Approval of ORLADEYO(TM) (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema PatientsBioCrystRHEA-AIneutral
12/03/20 8:28 AMNASDAQ : VIVEViveve Announces FDA 510K Approval to Expand Manufacturing of Treatment TipsViveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women'sRHEA-AIvery positive
12/03/20 7:30 AMNasdaq : OMERCMS Confirms Continued Separate Payment for Omeros' FDA-Approved OMIDRIA(R) in Ambulatory Surgery CentersOmeros Corporation (Nasdaq: OMER) announced today that the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros' cataract surgery drug OMIDRIA(R) (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system (OPPS) and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate paymentRHEA-AIneutral
12/01/20 6:22 PMNasdaq : VNDAFDA Approves HETLIOZ(R) (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis SyndromeVanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ (R) (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttimeRHEA-AIpositive
12/01/20 3:15 PMNasdaq : BPMCBlueprint Medicines Announces FDA Approval of GAVRETO(TM) (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid CancerBlueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved GAVRETO(TM)RHEA-AIvery positive
12/01/20 7:30 AMNasdaq : MBRXMoleculin Announces FDA Approves 3 Rare Pediatric Disease Designations for WP1066Moleculin 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 US Food and Drug Administration (FDA)RHEA-AIvery positive
11/30/20 8:30 AMNasdaq : CERSCerus Corporation Announces FDA Approval for INTERCEPT Blood System for CryoprecipitationCerus Corporation (Nasdaq: CERS) today announced that the US Food and Drug Administration (FDA) has granted approval of the INTERCEPT Blood System for Cryoprecipitation. The system is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. After thawing, Pathogen Reduced Cryoprecipitated Fibrinogen Complex remains transfusion-ready at rooRHEA-AIpositive
11/27/20 7:30 AMNasdaq : RYTMRhythm Pharmaceuticals Announces FDA Approval of IMCIVREE(TM) (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR DeficiencyApproval supports company's approach to address rare genetic diseases of obesity associated with an impaired MC4RHEA-AIneutral
11/25/20 5:02 PMNasdaq : YMABFDA Approves Y-mAbs' DANYELZA(R) (naxitamab-gqgk) for the Treatment of NeuroblastomaY-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announcedRHEA-AIvery positive
11/25/20 8:42 AMNasdaq : EIGREiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid LaminopathiesEiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Zokinvy (TM)RHEA-AIpositive
11/25/20 8:30 AMNasdaq : RVNCFDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site InspectionFDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel RestrictionsRHEA-AIvery positive
11/24/20 7:00 AMNasdaq : ALNYAlnylam Announces U.S. Food and Drug Administration (FDA) Approval of OXLUMO(TM) (lumasiran), the First and Only Treatment Approved for Primary Hyperoxaluria Type 1 to Lower Urinary Oxalate Levels in Pediatric and Adult PatientsAlnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved OXLUMO(TM) (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. PH1 is an ultra-rare genetic disease characterized by oxalate overproduction. The excess productionRHEA-AIneutral
11/23/20 4:05 PMNasdaq : APYXApyx Medical Corporation Announces Approval from FDA to Begin Phase II of U.S. IDE StudyApyx Medical Corporation (NASDAQ:APYX) (the "Company"), a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion(R) in the cosmetic surgery market and J-Plasma(R) in the hospital surgical market, today announced it received approval from the FDA to begin Phase II of its U.S. IDE clinical study evaluating the use of its Renuvion(R) technology in skin laxity procedures in the neck and submental region. "We arRHEA-AIneutral
11/23/20 3:34 PMNasdaq : VTRSViatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFARViatris Inc. (NASDAQ: VTRS), a new kind of healthcare company, today announced tentative approval from the U.S. Food and Drug Administration (FDA) for a New Drug Application for pediatric dolutegravir tablets for oral suspension, 10 mg. The new formulationRHEA-AIneutral
11/20/20 5:53 PMNasdaq : EIGREiger BioPharmaceuticals Announces FDA Approval of Zokinvy(TM) (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid LaminopathiesEiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Zokinvy TMRHEA-AIpositive
11/20/20 8:08 AMNasdaq : HOLXAptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV InfectionAptima(R) HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV InfectionRHEA-AIneutral
11/18/20 4:01 PMNasdaq : LNTHLantheus Holdings, Inc. Announces FDA Approval of DEFINITY(R) Room TemperatureLantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY(R) Room Temperature (DEFINITY RT) (Perflutren LRHEA-AIvery positive
11/13/20 8:26 PMNYSE : AAgilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast CancerAgilent Technologies Inc. (NYSE: A) today announced it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA(R) (pembrolizumab). PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible fRHEA-AIvery positive
11/13/20 4:10 PMNYSE : MRKFDA Approves Merck's KEYTRUDA(R) (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (CPS >=10)FDA Approves KEYTRUDA Plus Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic TNBC Whose Tumors Express PD-L1 (CPS >=10)RHEA-AIneutral
11/11/20 7:30 AMNasdaq : XAIRBeyond Air(R) Submits Premarket Approval Application to FDA for LungFit(TM) PH to Treat Persistent Pulmonary Hypertension of the NewbornPotential to revolutionize nitric oxide therapy by eliminating need for cumbersome cylinders creating im proved economics and safety in hospital setting Will be subject to a 180-day review period by the FDA Launch expected in 2Q 2021, pending approval GARDEN CITY, N.Y., Nov. 11, 2020 (GLOBERHEA-AIneutral
11/06/20 2:16 PMNasdaq : LGNDLigand's Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT(TM) for the Treatment of Status Epilepticus in Adult and Pediatric PatientsLigand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner Sedor Pharmaceuticals, LLC has received approval from the U.S. Food and Drug Administration (FDA) for SESQUIENT, a Captisol-enabled(TM) Fosphenytoin (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. Ready-to-dilute and room temperature stable, SESQUIENT is the only FDA-approved fosphenytoin that allows point-of-care storage, as wRHEA-AIvery positive
11/02/20 9:41 AMNYSE : BSXBoston Scientific Receives FDA Approval for the Ranger(TM) Drug-Coated BalloonBoston Scientific (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the Ranger(TM) Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoralRHEA-AIpositive
10/27/20 8:30 AMNasdaq : SLPFirst Approved Cancer Treatment for TGCT Included DILIsym Simulations in FDA ReviewDILIsym Services, an SLP company, announced today that analysis with DILIsym software was cited in the FDA review of Turalio(R), approved to treat TGCT.RHEA-AIneutral
10/27/20 7:00 AMNasdaq : KALAKala Pharmaceuticals Announces FDA Approval of EYSUVIS(TM) for the Short-Term Treatment of the Signs and Symptoms of Dry Eye DiseaseKala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. "The FDA approval of EYSUVIS as the first prescriptionRHEA-AIneutral
