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AISA Pharma receives FDA orphan drug designation for AISA-021, a treatment for systemic sclerosis

Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is...

Citius Pharmaceuticals' LYMPHIR™ wins FDA approval for relapsed/refractory cutaneous T-cell lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...

Biotheryx Announces First Patient Dosed in Phase 1 Clinical Trial of BTX-9341

Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, announced that the first patient has been dosed in its...

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...

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...

Nested Therapeutics Receives FDA Clearance for IND Application of NST-628, a Groundbreaking Pan-RAF/MEK Molecular Glue

Nested Therapeutics, a biotechnology company pioneering a next-generation precision medicine platform to address hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND)....

Akebia's Vafseo® (vadadustat) Tablets FDA Approved for Anemia Treatment in Dialysis Patients

Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat)....

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S....

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