https://www.biopharmawatch.com/news/BRNS/barinthus-bio-update-clywedog-therapeutics-merger BiopharmaWatch en 2026-08-24T22:57:00.000Z Barinthus Bio Provides Update on Proposed Combination with Clywedog Therapeutics https://www.biopharmawatch.com/news/ALKS/vibrance-1-phase-2-study-alixorexton-narcolepsy BiopharmaWatch en 2026-08-24T22:30:00.000Z The Lancet Neurology Publishes Data From Alkermes’ Positive Vibrance-1 Phase 2 Study of Alixorexton in Adults With Narcolepsy Type 1 https://www.biopharmawatch.com/news/BLCO/bausch-lomb-first-in-class-eye-health-therapies BiopharmaWatch en 2026-08-24T20:30:00.000Z Bausch + Lomb Advancing Two First-in-Class Eye Health Therapies Based on Trial Results https://www.biopharmawatch.com/news/SVRA/savara-phase-3-molgramostim-ers-congress-2026 BiopharmaWatch en 2026-08-24T20:05:00.000Z Savara Announces Encore Presentations of Results from the Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (APAP) at the European Respiratory Society (ERS) Congress 2026 https://www.biopharmawatch.com/news/AVLN/avalyn-presentations-european-respiratory-society-congress-2026 BiopharmaWatch en 2026-08-24T20:01:27.000Z Avalyn Announces Multiple Presentations at the European Respiratory Society International Congress 2026 https://www.biopharmawatch.com/news/LKFT/fda-orphan-drug-status-gamgertamig-pemphigus BiopharmaWatch en 2026-08-24T20:01:00.000Z Amerikaanse FDA kent weesgeneesmiddelstatus toe aan Gamgertamig voor de behandeling van Pemphigus https://www.biopharmawatch.com/news/LKFT/us-fda-orphan-drug-designation-gamgertamig-pemphigus BiopharmaWatch en 2026-08-24T20:01:00.000Z U.S. FDA Grants Orphan Drug Designation to Gamgertamig for the Treatment of Pemphigus https://www.biopharmawatch.com/news/ORKA/oruka-therapeutics-appoints-todd-edwards-cco BiopharmaWatch en 2026-08-24T20:01:00.000Z Oruka Therapeutics Appoints Todd Edwards as Chief Commercial Officer https://www.biopharmawatch.com/news/BLTE/belite-bio-virtual-commercial-day-september-2026 BiopharmaWatch en 2026-08-24T20:00:00.000Z Belite Bio to Host Virtual Commercial Day on September 2, 2026 https://www.biopharmawatch.com/news/ACB/curaleaf-responds-aurora-cannabis-shareholder-value BiopharmaWatch en 2026-08-24T19:45:00.000Z Curaleaf Responds to Aurora Cannabis' Latest Attempt to Deflect From Shareholder Value Creation https://www.biopharmawatch.com/news/COSM/cosmos-health-oliv18-revenue-projections BiopharmaWatch en 2026-08-24T19:40:00.000Z Cosmos Health Projects Over $6M in Annual Revenue and $4.3M in Gross Profit from Oliv18™ Across the U.S. Cardiovascular Health and Antioxidant Categories https://www.biopharmawatch.com/news/MRNA/moderna-merck-cancer-vaccine-success-cancervax BiopharmaWatch en 2026-08-24T19:30:00.000Z Moderna and Merck Cancer Vaccine Success Is Good News for CancerVax https://www.biopharmawatch.com/news/GH/guardant-health-appeal-federal-court-judgment BiopharmaWatch en 2026-08-24T18:44:00.000Z Guardant Health to Appeal Federal District Court Judgment https://www.biopharmawatch.com/news/ACAD/european-commission-approves-daybu-trofinetide-rett-syndrome BiopharmaWatch en 2026-08-24T14:29:00.000Z Riassunto: La Commissione europea approva DAYBU® (trofinetide) come primo e unico trattamento dei sintomi neuro-comportamentali della sindrome di Rett nell'Unione Europea https://www.biopharmawatch.com/news/BCTX/briacell-advances-personalized-melanoma-immunotherapy BiopharmaWatch en 2026-08-24T14:20:44.000Z BriaCell Advances Personalized Melanoma Immunotherapy Vaccine Candidate, Bria-MEL+(TM) https://www.biopharmawatch.com/news/QGEN/qiagen-appoints-jonathan-pratt-ceo BiopharmaWatch en 2026-08-24T13:47:00.000Z QIAGEN Appoints Jonathan M. Pratt as Chief Executive Officer https://www.biopharmawatch.com/news/QGEN/qiagen-appoints-jonathan-pratt-ceo BiopharmaWatch en 2026-08-24T13:47:00.000Z QIAGEN ernennt Jonathan M. Pratt zum Vorstandsvorsitzenden https://www.biopharmawatch.com/news/CAPR/capricor-therapeutics-fda-deramiocel-pdufa-extension BiopharmaWatch en 2026-08-24T13:25:00.000Z Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA https://www.biopharmawatch.com/news/LEXX/dehydratech-enhanced-amycretin-retatrutide-absorption-improvements BiopharmaWatch en 2026-08-24T13:11:38.000Z DehydraTECH™-enhanced Amycretin and Retatrutide Yield Significant Absorption Improvements in Lexaria’s 2026 Animal Study #2 https://www.biopharmawatch.com/news/GRI/gri-bio-presents-phase-2a-data-ers-2026 BiopharmaWatch en 2026-08-24T13:05:00.000Z GRI Bio to Present Late-Breaking Phase 2a GRI-0621 Data Highlighting Lung Function, Anti-Fibrotic Biomarkers and Favorable Tolerability in IPF at ERS 2026 https://www.biopharmawatch.com/news/DGX/quest-diagnostics-morgan-stanley-healthcare-conference BiopharmaWatch en 2026-08-24T13:00:00.000Z Quest Diagnostics to Speak at the Morgan Stanley 24th Annual Global Healthcare Conference https://www.biopharmawatch.com/news/STLN/starling-oncology-wells-fargo-conference-2026 BiopharmaWatch en 2026-08-24T13:00:00.000Z Starling Oncology to Participate in Wells Fargo Healthcare Conference https://www.biopharmawatch.com/news/ANIX/anixa-biosciences-presentation-cantor-fitzgerald-2026 BiopharmaWatch en 2026-08-24T12:55:00.000Z Anixa Biosciences to Present at the 2026 Cantor Fitzgerald Global Healthcare Conference Highlighting its Breast Cancer Vaccine and Ovarian Cancer CAR-T Therapy https://www.biopharmawatch.com/news/SPRC/scisparc-neurothera-clearmind-mdma-ptsd BiopharmaWatch en 2026-08-24T12:51:00.000Z SciSparc: NeuroThera-Clearmind Collaboration Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal Support for Psychedelic Innovation https://www.biopharmawatch.com/news/IONS/gsk-hibsago-approval-japan-hepatitis-b BiopharmaWatch en 2026-08-24T12:47:00.000Z Ionis partner GSK announces Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B https://www.biopharmawatch.com/news/ALNY/alnylam-esc-congress-2026-data-presentation BiopharmaWatch en 2026-08-24T12:33:00.000Z Alnylam to Present New Data Reinforcing Strength in RNAi-Powered TTR Silencing and Continued Progress in Hypertension at ESC Congress 2026 https://www.biopharmawatch.com/news/WGS/genedx-rapid-genomic-sequencing-seattle-childrens BiopharmaWatch en 2026-08-24T12:30:00.000Z GeneDx Announces Transformative Study Supporting Hospital-Wide Adoption of Rapid Genomic Sequencing at Seattle Children’s https://www.biopharmawatch.com/news/FBLG/fibrobiologics-appoints-leigh-steinberg-board BiopharmaWatch en 2026-08-24T12:30:00.000Z FibroBiologics Appoints Leigh Steinberg to Board of Directors https://www.biopharmawatch.com/news/BCDA/biocardia-fda-helix-catheter-approval BiopharmaWatch en 2026-08-24T12:30:00.000Z BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval https://www.biopharmawatch.com/news/CVRX/cvrx-devoted-health-coverage-barostim-therapy BiopharmaWatch en 2026-08-24T12:30:00.000Z CVRx Announces Devoted Health Medicare Advantage Coverage Policy for Barostim Therapy https://www.biopharmawatch.com/news/LXRX/lexicon-pharmaceuticals-lx9851-phase-1-milestone BiopharmaWatch en 2026-08-24T12:30:00.000Z Lexicon Pharmaceuticals Earns Third $10 Million Milestone Payment from Novo Nordisk Following Achievement of Key Phase 1 Development Milestone for LX9851 https://www.biopharmawatch.com/news/AMRN/reduce-it-esc-congress-2026-presentations BiopharmaWatch en 2026-08-24T12:15:00.000Z New Analyses from REDUCE-IT® and EPA Mechanistic Data to be Presented at the European Society of Cardiology (ESC) Congress 2026 https://www.biopharmawatch.com/news/RKTO/rocket-one-attend-idga-counter-uas-summit-2026 BiopharmaWatch en 2026-08-24T12:08:00.000Z Rocket One Inc. to Attend IDGA’s Counter UAS Summit August 25 – 26, 2026 https://www.biopharmawatch.com/news/BIIB/leqembi-iqlik-autoinjector-alzheimers-therapy BiopharmaWatch en 2026-08-24T12:04:27.000Z LEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer’s Disease https://www.biopharmawatch.com/news/BIIB/leqembi-iqlik-autoinjector-alzheimers-therapy BiopharmaWatch en 2026-08-24T12:00:00.000Z LEQEMBI IQLIK®(lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer's Disease https://www.biopharmawatch.com/news/PTCT/ptc-therapeutics-sephience-data-ssieme-symposium BiopharmaWatch en 2026-08-24T12:00:00.000Z PTC Therapeutics Announces New Sephience™ (sepiapterin) Data Reinforcing Broad Patient Benefits Including Sustained Metabolic Control and Diet Liberalization as well as Consistent Favorable Safety Profile https://www.biopharmawatch.com/news/EWTX/edgewise-therapeutics-esc-congress-2026-presentation BiopharmaWatch en 2026-08-24T12:00:00.000Z Edgewise Therapeutics Announces Upcoming Late-Breaking Science Presentation at the European Society of Cardiology (ESC) Congress 2026 https://www.biopharmawatch.com/news/ERAS/erasca-fda-fast-track-eras-0015-pancreatic-cancer BiopharmaWatch en 2026-08-24T12:00:00.000Z Erasca Granted FDA Fast Track Designation for Pan-RAS Molecular Glue ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma https://www.biopharmawatch.com/news/AEON/aeon-biopharma-dr-lee-acting-cro BiopharmaWatch en 2026-08-24T12:00:00.000Z AEON Biopharma Designates Former FDA Neuroscience Leader Paul Lee, M.D., Ph.D. as Acting Chief Regulatory Officer https://www.biopharmawatch.com/news/BNGO/bionano-participate-hc-wainwright-investment-conference BiopharmaWatch en 2026-08-24T12:00:00.000Z Bionano to Participate in the H.C. Wainwright 28th Annual Global Investment Conference https://www.biopharmawatch.com/news/LIMN/liminatus-pharma-synex-cro-phase-1-2a-clinical-trial BiopharmaWatch en 2026-08-24T12:00:00.000Z Liminatus Pharma Engages Synex as Contract Research Organization to Support Phase 1/2a Clinical Development of CD19xCD22 bivalent CAR-T therapy https://www.biopharmawatch.com/news/HUMA/humacyte-supplemental-bla-filing-dialysis-access BiopharmaWatch en 2026-08-24T12:00:00.000Z Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions https://www.biopharmawatch.com/news/ELTX/elicio-therapeutics-wells-fargo-healthcare-conference BiopharmaWatch en 2026-08-24T12:00:00.000Z Elicio Therapeutics to Participate at the Wells Fargo 21st Annual Healthcare Conference https://www.biopharmawatch.com/news/RYTM/rhythm-pharmaceuticals-imcivree-approval-japan BiopharmaWatch en 2026-08-24T12:00:00.000Z Rhythm Pharmaceuticals Announces MHLW Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity (HO) in Japan https://www.biopharmawatch.com/news/SPRB/spruce-biosciences-positive-pre-bla-fda-meetings BiopharmaWatch en 2026-08-24T12:00:00.000Z Spruce Biosciences Announces Positive Pre-BLA Meetings with FDA and Confirms BLA Submission for TA-ERT on Track for Q4 2026 https://www.biopharmawatch.com/news/ARWR/arrowhead-pharmaceuticals-esc-congress-presentation BiopharmaWatch en 2026-08-24T11:30:00.000Z Arrowhead Pharmaceuticals to Present New Clinical Data at the European Society of Cardiology Congress https://www.biopharmawatch.com/news/BBIO/bridgebio-acoramidis-data-esc-congress-2026 BiopharmaWatch en 2026-08-24T11:30:00.000Z BridgeBio to Present New Acoramidis Data from Open-Label Extension Analyses in ATTR-CM at ESC Congress 2026 https://www.biopharmawatch.com/news/BCTX/briacell-advances-personalized-melanoma-immunotherapy BiopharmaWatch en 2026-08-24T11:30:00.000Z BriaCell Advances Personalized Melanoma Immunotherapy Vaccine Candidate, Bria-MEL+™ https://www.biopharmawatch.com/news/ABUS/arbutus-230-million-tender-offer-shares BiopharmaWatch en 2026-08-24T11:30:00.000Z Arbutus Commences US$230 Million Modified “Dutch Auction” Tender Offer of its Common Shares at a Price Not Greater Than US$5.75 Nor Less Than US$5.00 Per Share https://www.biopharmawatch.com/news/DGX/quest-diagnostics-fda-cleared-pTau217-blood-test-alzheimers BiopharmaWatch en 2026-08-24T11:24:00.000Z Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology https://www.biopharmawatch.com/news/RGNX/regenxbio-regulatory-update-rgx-121-mps-ii BiopharmaWatch en 2026-08-24T11:05:00.000Z REGENXBIO Announces Regulatory Update on RGX-121 for MPS II https://www.biopharmawatch.com/news/ACB/aurora-cannabis-curaleaf-hostile-bid-response BiopharmaWatch en 2026-08-24T11:05:00.000Z AURORA CANNABIS CORRECTS INACCURATE STATEMENTS MADE IN SUPPORT OF CURALEAF HOLDINGS' HOSTILE BID https://www.biopharmawatch.com/news/LH/labcorp-fda-cleared-blood-test-alzheimers-disease BiopharmaWatch en 2026-08-24T11:02:00.000Z Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer's Disease Pathology in Both Primary and Specialty Care Settings https://www.biopharmawatch.com/news/GH/twinstrand-biosciences-guardant-health-patent-infringement BiopharmaWatch en 2026-08-24T11:00:00.000Z TwinStrand Biosciences Announces Final Judgment in Patent Infringement Suit Against Guardant Health, Awarding TwinStrand and the University of Washington More Than $245.2 Million in Damages, Accrued Royalties and Interest https://www.biopharmawatch.com/news/ANTX/an2-therapeutics-appoints-cameron-trenor-cmo BiopharmaWatch en 2026-08-24T11:00:00.000Z AN2 Therapeutics Appoints Cameron Trenor, M.D., as Chief Medical Officer https://www.biopharmawatch.com/news/UTHR/fda-acceptance-ralinepag-pah-uthr BiopharmaWatch en 2026-08-24T11:00:00.000Z United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension https://www.biopharmawatch.com/news/SCNI/scinai-first-half-2026-highlights-results BiopharmaWatch en 2026-08-24T11:00:00.000Z Scinai Reports First Half 2026 Corporate Highlights and Results with Spotlight on Growing CDMO Momentum https://www.biopharmawatch.com/news/INSM/brinsupr-approved-japan-non-cystic-fibrosis-bronchiectasis BiopharmaWatch en 2026-08-24T11:00:00.000Z BRINSUPRI® (brensocatib) Approved by Japan's Ministry of Health, Labour and Welfare for the Treatment of Patients With Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease https://www.biopharmawatch.com/news/PLSM/pulsenmore-announces-financial-results-2026 BiopharmaWatch en 2026-08-24T11:00:00.000Z Pulsenmore Ltd. To Announce Financial Results and Business Highlights and Hold Conference Call for the First Half of 2026 https://www.biopharmawatch.com/news/VNDA/vanda-orphan-designation-imsidolimab-gpp-eu BiopharmaWatch en 2026-08-24T11:00:00.000Z Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission https://www.biopharmawatch.com/news/VRXA/veraxa-secarna-research-milestone-antibody-oligonucleotide BiopharmaWatch en 2026-08-24T11:00:00.000Z VERAXA Biotech and Secarna Pharmaceuticals Achieve Research Milestone in Antibody Oligonucleotide Conjugate (AOC) Alliance https://www.biopharmawatch.com/news/TLSA/tiziana-life-sciences-banyan-trial-als-nexus-2026 BiopharmaWatch en 2026-08-24T11:00:00.000Z Tiziana Life Sciences Announces Poster Presentation on Phase 2a BANYAN Clinical Trial of Intranasal Foralumab at ALS Nexus 2026 https://www.biopharmawatch.com/news/INCR/intercure-settlement-war-damages-nir-oz-facility BiopharmaWatch en 2026-08-24T11:00:00.000Z InterCure Finalizes NIS 230 Million (~US$77 Million) Settlement for War-Related Indirect Damages https://www.biopharmawatch.com/news/BMEA/biomea-fusion-completes-enrollment-covalent-211-trial BiopharmaWatch en 2026-08-24T11:00:00.000Z Biomea Fusion Announces Completion of Enrollment in COVALENT-211 Phase II Trial of Icovamenib in Insulin-Deficient Type 2 Diabetes https://www.biopharmawatch.com/news/RAPP/rapport-therapeutics-kol-event-bipolar-mania-rap-219 BiopharmaWatch en 2026-08-24T11:00:00.000Z Rapport Therapeutics to Host Virtual KOL Event on the Unmet Need in Bipolar Mania and the RAP-219 Clinical Program https://www.biopharmawatch.com/news/GLUE/monte-rosa-therapeutics-modefire-1-phase-2-study BiopharmaWatch en 2026-08-24T11:00:00.000Z Monte Rosa Therapeutics Announces First Patient Dosed in MODeFIRe-1, a Phase 2 Study of MRT-2359 in Combination with Apalutamide in Patients with AR Mutation-Positive Metastatic Castration-Resistant Prostate Cancer https://www.biopharmawatch.com/news/ANIP/ani-pharmaceuticals-appoints-henry-gosebruch-board BiopharmaWatch en 2026-08-24T10:55:00.000Z ANI Pharmaceuticals Appoints Henry Gosebruch to Board of Directors https://www.biopharmawatch.com/news/GILD/gilead-trodelvy-expands-role-tnbc BiopharmaWatch en 2026-08-24T10:31:00.000Z European Commission Expands Role of Gilead’s Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer Across PD-L1 Status https://www.biopharmawatch.com/news/DTIL/precision-biosciences-dosing-phase-1-2-function-dmd-study BiopharmaWatch en 2026-08-24T10:01:00.000Z Precision BioSciences Commences Dosing in Phase 1/2 FUNCTION-DMD Study https://www.biopharmawatch.com/news/OCS/first-patient-treated-pioneer-1-trial-privosegtor-optic-neuritis BiopharmaWatch en 2026-08-24T08:00:00.000Z First Patient Treated in PIONEER-1 Registrational Trial of Privosegtor for Optic Neuritis https://www.biopharmawatch.com/blog/biotech-catalysts-to-watch-week-of-2026-08-24 BiopharmaWatch en 2026-08-24T07:15:32.636Z Biotech Catalysts to Watch: Key Developments for Q4 2026 https://www.biopharmawatch.com/news/ACAD/european-commission-approves-daybu-trofinetide-rett-syndrome BiopharmaWatch en 2026-08-24T07:01:00.000Z European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union https://www.biopharmawatch.com/news/ACAD/daybu-approval-rett-syndrome-eu BiopharmaWatch en 2026-08-24T07:01:00.000Z De Europese Commissie keurt DAYBU® (trofinetide) goed als eerste en enige behandeling voor neurologische gedragssymptomen van het Rett-syndroom in de Europese Unie https://www.biopharmawatch.com/news/TAK/orzeiful-oveporexton-approval-japan-narcolepsy BiopharmaWatch en 2026-08-24T06:36:00.000Z ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 1