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40+ results for “ruxolitinib extended release bioequivalence”
- NewsFDA approves Incyte’s Jakafi XR for myelofibrosis, polycythemia vera, and graft-versus-host diseaseIncyte has received US FDA approval for Jakafi Xr (ruxolitinib) extended-release tablets, a once-daily reformulation of its established JAK1/JAK2 inhibitor, across three…
- NewsEU approval extended to AbbVie’s Aquipta for acute migraineThe European Commission has approved Aquipta (atogepant) for the acute treatment of migraine with or without aura in adults, expanding the oral…
- DevelopmentVeradermics' oral minoxidil meets endpoints in Phase II/III male pattern hair loss trialVeradermics (NYSE: MANE) reported that its extended-release oral minoxidil tablet, VDPHL01, met all primary and key secondary endpoints in a Phase II/III...
- NewsFDA approves Regeneron’s Eylea HD for extended five-month dosing intervalThe US FDA approved an extended dosing interval for Eylea HD (aflibercept), allowing Regeneron Pharmaceuticals to label the 8 mg intravitreal injection…
- DevelopmentAnixa's FSHR-directed CAR-T shows extended survival in recurrent ovarian cancerSurvival data from a follicle-stimulating hormone receptor-targeted CAR-T therapy in recurrent ovarian cancer are adding to a limited evidence base for cell...
- DevelopmentSanofi's amlitelimab meets Phase III endpoints in atopic dermatitis with extended 12-week dosing intervalSanofi (NASDAQ: SNY) reported Phase III data from three trials of amlitelimab in moderate-to-severe atopic dermatitis, showing that the anti-OX40L antibody...
- DevelopmentKaryopharm's XPO1 plus JAK inhibitor regimen both hits and misses in Phase III myelofibrosis trialNewton, Massachusetts-based Karyopharm Therapeutics (Nasdaq: KPTI) reported that selinexor (Xpovio) combined with ruxolitinib nearly doubled the spleen...
- DevelopmentSpyre's SPY002 sets anti-TL1A bar with largest histopathology win in ulcerative colitisSPY002, Waltham, Massachusetts-based Spyre Therapeutics' (Nasdaq: SYRE) extended half-life anti-TL1A antibody, produced a statistically significant...
- BusinessBayer completes USD 2.45b purchase of Perfuse for first-in-class endothelin antagonist Bayer has completed its acquisition of Perfuse Therapeutics, gaining full global rights to PER-001, a first-in-class sustained-release endothelin receptor...
- DevelopmentOtsuka reports positive Phase IIIb anxiety data as centanafadine nears July FDA decisionOtsuka has reported positive Phase IIIb results for centanafadine sustained-release in adults with ADHD and comorbid anxiety, a readout that matters because...
- NewsCalciMedica halts Phase II kidney injury study for Auxora due to safety concernsCalciMedica, Inc., a specialist in calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases, called a halt to a…
- NewsKorsana Bio emerges from stealth with USD 175m to advance THETA shuttle antibody for Alzheimer’sKorsana Biosciences, a Waltham, Massachusetts-based biotechnology company focused on neurodegenerative diseases, issued a press release announcing it has emerged from stealth with…
- DevelopmentViatris clears path to Japan NDA for VR-205 in IgA nephropathyViatris Inc. (Nasdaq: VTRS) reported positive top-line results from a Phase III bridging study of VR-205 (targeted-release budesonide) in Japanese adults...
- BusinessVima Therapeutics Extends Series A to USD 100 Million, Begins Dosing Dystonia Phase 2 TrialCambridge, Massachusetts-based Vima Therapeutics, a clinical-stage company developing oral therapies for movement disorders, has extended its Series A...
- NewsNavigator Medicines puts OX40L/TNFα BsAbs into trials for inflammatory skin diseaseNew Jersey-based biotech Navigator Medicines is advancing two bispecific antibodies targeting OX40L and TNFα into clinical development, marking a significant progression in…
- Regulatory & PolicyPharvaris advances first bradykinin B2 antagonist for on-demand HAE treatment to FDA reviewPharvaris N.V. (Nasdaq: PHVS) has submitted a New Drug Application to the US FDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand...
- DevelopmentCandel's genetic therapy set for BLA in prostate cancer after showing 39% improvement in disease-free survivalCandel Therapeutics (Nasdaq: CADL) reported extended follow-up data from its Phase III trial of aglatimagene besadenovec in localized prostate cancer...
- DevelopmentLuye Pharma starts China Phase II for TAAR1/5-HT2CR dual agonist in schizophrenia Luye Pharma announced on April 8 that the first subject has been enrolled in the Phase II clinical trial in China of LY03020, an oral controlled-release...
- BusinessKaro expands license with Moberg Pharma to include China e-commerceKaro Healthcare has extended its license agreement with Stockholm-based Moberg Pharma (Nasdaq Stockholm: MOB) to cover China, adding the world's most...
- Regulatory & PolicyFDA delays review of Savara's molgramostim inhalation solution for autoimmune PAP to NovemberThe US FDA has extended its review period for the Biologics License Application (BLA) submitted by Savara Inc. for molgramostim inhalation solution...
- Regulatory & PolicyFDA adds 3 months to review of Eisai's Leqembi Iqlik subcutaneous formulation for early Alzheimer's The US FDA has extended its review of a supplemental application for Leqembi Iqlik (lecanemab-irmb), pushing the PDUFA date for the subcutaneous...
- Regulatory & PolicyFDA extends review of Beren Therapeutics' adrabetadex for infantile-onset Niemann-Pick disease type CBeren Therapeutics has announced that the US FDA has extended by three months its review of the New Drug Application (NDA) for adrabetadex...
- NewsTanabe’s oral MC1R agonist dersimelagon extends pain-free light exposure in Phase III EPP/XLP trialTanabe Pharma Corporation reported that dersimelagon, an investigational oral melanocortin 1 receptor (MC1R) agonist, significantly extended pain-free sunlight exposure in patients with…
- Regulatory & PolicyFDA extends review of Orca Bio's Orca-T for hematologic malignancies to July 2026Orca Bio has announced that the US FDA extended the review timeline for its Biologics License Application (BLA) for Orca-T, an investigational allogeneic...
- BusinessCellares raises USD 327m to scale automated cell therapy manufacturing globallySouth San Francisco-based Cellares has extended its Series D financing to USD 327 million following a USD 50 million growth equity investment from Prime...
- Regulatory & PolicyFDA delays decision on AstraZeneca's camizestrant after ODAC reverseAstraZeneca (LSE/STO/NYSE: AZN) has disclosed that the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the New Drug Application...
- DevelopmentSpyre's SPY001 meets primary endpoint in Phase II ulcerative colitis induction trialSpyre Therapeutics (Nasdaq: SYRE) reported that SPY001, its extended half-life anti-α4β7 antibody, met the primary endpoint in the open-label Part A of the...
- DevelopmentOruka Therapeutics' ORKA-001 achieves 63.5% complete skin clearance in plaque psoriasis trialOruka Therapeutics reported Week 16 interim results from the EVERLAST-A Phase 2a trial of ORKA-001, a half-life extended IL-23p19 monoclonal antibody, in...
- DevelopmentKaryopharm's selinexor doubles spleen response in myelofibrosis but misses symptom endpoint in Phase IIIKaryopharm Therapeutics (Nasdaq: KPTI) reported topline results from its Phase III SENTRY trial in myelofibrosis, showing that selinexor combined with...
- BusinessIpsen buys Kartos to add Phase III MDM2 inhibitor for myelofibrosisFrance-based Ipsen (Euronext: IPN; ADR: IPSEY) has agreed to acquire Kartos Therapeutics, a Redwood City, California-based clinical-stage company, in a...
- DevelopmentTeva reports early vitiligo data for anti-IL-15 TEV-'408, advances into Phase IIbTeva Pharmaceutical Industries (NYSE and TASE: TEVA) reported Phase Ib data for TEV-'408, its internally discovered anti-IL-15 monoclonal antibody, and...
- NewsVanda takes FDA approval for Bysanti as 1st-line schizophrenia, bipolar therapyUS-based Vanda Pharmaceuticals unveiled US FDA approval for Bysanti (milsaperidone) indicated to treat schizophrenia in adults and the acute treatment of manic…
- DevelopmentTG Therapeutics' ublituximab-xiiy meets primary endpoint in Phase IIIb relapsing multiple sclerosis trialTG Therapeutics (Nasdaq: TGTX) reported that its Phase III ENHANCE trial met its primary endpoint, demonstrating that a consolidated single 600 mg infusion...
- NewsOrca Bio’s Tregzi gets FDA nod as first allogeneic regulatory T cell therapy for transplant patientsThe US FDA approved Tregzi (HSPC and T cells-vldq), developed by Orca Bio, for use in matched donor hematopoietic stem cell transplantation…
- BusinessSanofi acquires global rights to rovadicitinib from Sino Biopharmaceutical in up to USD 1.53b dealChia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a subsidiary of Hong Kong-listed Sino Biopharmaceutical Limited (HKEX: 1177), has entered into an...
- DevelopmentPrelude Therapeutics Launches Phase 1 Trial of JAK2 Inhibitor PRT12396 in Myeloproliferative NeoplasmsPrelude Therapeutics Incorporated (Nasdaq: PRLD) has registered a Phase 1 clinical trial for PRT12396, a first-in-class, oral, allosteric inhibitor that...
- DevelopmentSkye Bioscience Nimacimab and Semaglutide Combination Demonstrates 22.3% Weight Loss in Phase 2a TrialSkye Bioscience [announced](https://www.globenewswire.com/news-release/2026/02/02/3230132/0/en/Skye-Reports-Positive-CBeyond-Phase-2a-Extension-Interim-Study-Results-for-Nimacimab-in-Combination-With-Semaglutide.html) positive clinical trial results for nimacimab, a peripherally-restricted CB1 inhibitor antibody, when combined with semaglutide in treating obesity. The Phase 2a CBeyond study demons
- BusinessCollegium acquires ADHD drug AZSTARYS from Corium Therapeutics for USD 650m plus milestonesCollegium Pharmaceutical, based in Stoughton, Massachusetts, announced a definitive agreement to acquire AZSTARYS from Corium Therapeutics Holdings for USD...
- NewsMaaT Pharma receives negative trend opinion from European Medicines Agency for XervytegMaaT Pharma (Euronext: MAAT), based in Lyon, France, received a “negative trend” opinion from the European Medicines Agency’s Committee for Medicinal Products…
- BusinessEli Lilly acquires Ajax Therapeutics for USD 2.3b targeting myeloproliferative neoplasm treatmentsEli Lilly (NYSE: LLY) has agreed to acquire US-based Ajax Therapeutics, a private New York-incorporated biopharmaceutical company, for up to USD 2.3 billion...