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PharmAbcine's Phase 1 Trial of PMC-403 for Neovascular Age-Related Macular Degeneration Advances to Single-Dose (4mg) and Multiple-Dose (3mg)

PharmAbcine, Inc. a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today the decision to advance PMC-403, its candidate treatment for neovascular age-related macular degeneration...

Kedrion Selected by Biotest to Distribute FDA-Approved Immunoglobulin Yimmugo® in the U.S

Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full commercialization and distribution of the immunoglobulin therapy Yimmugo® in the U.S., following its Biologic License...

FDA Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Relapsed or Refractory Follicular Lymphoma

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or...

CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis

CalciMedica Inc. a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, announced positive topline...

BioMarin to Present Data Showcasing VOXZOGO® (vosoritide)'s Impact on Bone Health and Quality of Life in Achondroplasia

BioMarin Pharmaceutical Inc. announced the presentation of new data from an investigator-led analysis of the Phase 2 111-205 study, which demonstrate that children with achondroplasia treated with VOXZOGO® experienced increases in bone length...

Immorta Bio Reports Successful Lung Cancer Growth Inhibition by Senolytic Immunotherapy SenoVax™

Immorta Bio Inc, a science-based Life Extension company announced today positive preclinical findings utilizing its senescent cell-killing immunotherapeutic product SenoVax™ in a model of non-small cell lung cancer. The results, which are reported...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

Thermo Fisher Scientific Introduces Innovative Mass Spectrometer to Advance Clinical Research

Thermo Fisher Scientific Inc the world leader in serving science, today unveiled the Thermo Scientific™ Stellar™ mass spectrometer (MS), a new solution that combines fast throughput, high sensitivity, and ease of use to allow researchers to...

LIB Therapeutics Announces Positive Lerodalcibep Results from Two Phase 3 LIBerate Studies

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, once-monthly, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced positive results from two studies in the...

Orthofix Receives FDA 510(k) Clearance for Rodeo™ Telescopic Nail

Orthofix Medical Inc. a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative...

FDA Clears Rika Plasma Donation System's Individualized Nomogram

Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma...

BioLineRx Unveils Poster Presentation on Economic Model Data for APHEXDA® in CD34+ Hematopoietic Stem Cell Mobilization

BioLineRx Ltd. a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem...

Adcentrx Therapeutics: China NMPA Clears IND for ADRX-0706, a Novel Nectin-4 ADC in Advanced Solid Tumor Treatment

Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, announced that China National Medical Products Administration (NMPA) has cleared...

enGene to Showcase Pivotal Phase 1/2 LEGEND Study Details of EG-70 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. (Nasdaq: ENGN) or ("enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today...

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection,...

TIVDAK® Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

Genmab A/S announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer...

Tentarix Biotherapeutics announces appointment of Andrew D. Kidd, MD, CFA, as CEO

Tentarix Biotherapeutics announced the appointment of Andrew Kidd, MD, as chief executive officer. Mr. Kidd joins Tentarix with a distinguished career of over two decades of executive and biotech experience. He was most recently the president and...

Factor Bioscience to Deliver Seven Presentations at the American Society of Gene & Cell Therapy

Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, announced its participation in the American Society of Gene & Cell Therapy. Factor will deliver seven presentations,...

ImmunityBio Announces FDA Approval of ANKTIVA®,

ImmunityBio, Inc. an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with...

Moleculin's AML treatment gets EMA's Orphan Drug Designation

Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, announced that the European Medicines Agency has...