TheraRadar

TheraRadar News archive

Pharma and biotech news by week, 834 stories in 12 finished weeks. Each week's page lists its stories by importance, with links to the original releases, filings and FDA letters. This week's news is on TheraRadar News.

  • Week of Nov 2 – Nov 8, 2026 · 147 stories
    • MHRA approves Pharming’s Joenja® (leniolisib) as first treatment specifically for children with APDS in the U.K. (Pharming)
    • Johnson & Johnson announces ICOTYDE® (icotrokinra) delivers significant improvement in psoriatic arthritis disease activity among biologic-naive patients with once-daily targeted oral peptide (Johnson & Johnson)
    • Bristol Myers Squibb Presents 56-Week Phase 3 Data in Pediatric Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) for Camzyos (mavacamten) at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions (Bristol Myers Squibb)
  • Week of Oct 26 – Nov 1, 2026 · 82 stories
    • Enhertu approved in the EU as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer (AstraZeneca)
    • Adults Living with Familial Chylomicronaemia Syndrome (FCS) in England and Wales Have REDEMPLO® (Plozasiran) as a New Treatment Option to Reduce Triglycerides (Arrowhead Pharmaceuticals)
    • Genmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer (Genmab)
  • Week of Oct 19 – Oct 25, 2026 · 103 stories
    • U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease (AbbVie)
    • Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB) (Ionis Pharmaceuticals)
    • Ultomiris received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy (AstraZeneca)
  • Week of Oct 12 – Oct 18, 2026 · 71 stories
    • Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia (Opus Genetics)
    • FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease (ImmunityBio)
    • New composite outcomes data show patients treated with Lilly's Omvoh (mirikizumab-mrkz) achieved comprehensive corticosteroid-free disease control in ulcerative colitis and corticosteroid-free deep remission in Crohn's disease at one year (Eli Lilly)
  • Week of Oct 5 – Oct 11, 2026 · 69 stories
    • FDA approves Roche's Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer (Roche)
    • FDA approves Hovilpri (pritelivir mesylate) (AICURIS ANTI-INFECT)
    • AbbVie and Genmab Announce Epcoritamab in Combination with R-CHOP Demonstrates Significant Improvement in Progression-Free Survival versus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (AbbVie)
  • Week of Sep 28 – Oct 4, 2026 · 89 stories
    • Lilly's Jaypirca (pirtobrutinib), the first-and-only approved non-covalent BTK inhibitor, receives expanded indication from U.S. FDA for certain patients with previously untreated CLL/SLL (Eli Lilly)
    • U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease (AbbVie)
    • FDA approves Camzyos (mavacamten) (Bristol Myers Squibb)
  • Week of Sep 21 – Sep 27, 2026 · 70 stories
    • U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) (Merck & Co.)
    • Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity (Rhythm)
    • Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for Subcutaneous Administration for All KEYTRUDA® (pembrolizumab) Indications Approved in Japan (Merck & Co.)
  • Week of Sep 14 – Sep 20, 2026 · 48 stories
    • FDA approves AQNEURSA (levacetylleucine) (IntraBio)
    • FDA approves Fayuvi (rebisufligene etisparvovec-hopf) (Ultragenyx)
    • Viatris Announces Approval of WAKIX® (Pitolisant) in Japan, a First-in-Class Treatment for Narcolepsy and Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Syndrome (Viatris)
  • Week of Sep 7 – Sep 13, 2026 · 50 stories
    • Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA) (Scholar Rock)
    • FDA approves Pharming’s Joenja® as first treatment for children with APDS in the U.S. (Pharming)
    • FDA approves Pixclara (floretyrosine f-18) (Telix)
  • Week of Aug 31 – Sep 6, 2026 · 49 stories
    • Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer (AstraZeneca)
    • LEQEMBI® (lecanemab) Subcutaneous Formulation as an Initiation Treatment for Early Alzheimer’s Disease Approved in China (Biogen)
    • Enhertu plus pertuzumab approved in the EU as first new regimen in more than a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (AstraZeneca)
  • Week of Aug 24 – Aug 30, 2026 · 42 stories
    • U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma (Zymeworks)
    • Ionis partner GSK announces Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B (Ionis Pharmaceuticals)
    • Roivant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S. (Roivant Sciences)
  • Week of Aug 17 – Aug 23, 2026 · 14 stories
    • Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP) (Regeneron)
    • FDA approves Genglycos (pariglasgene brecaparvovec-opnr) (Ultragenyx)
    • Milestone Pharmaceuticals Initiates Pivotal Phase 3 Trial of Etripamil Nasal Spray for Self-Administered Treatment of Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) (Milestone Pharmaceuticals)