New Indications and Dosage Forms for 2022
See also: New Drug Approvals for 2022
January 6, 2022
January 14, 2022
January 21, 2022
- FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
- U.S. FDA Approves Second Indication for Skyrizi (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
January 22, 2022
January 31, 2022
- FDA Approves Prophylactic Treatment with Vonvendi [von Willebrand Factor (Recombinant)] for Adult Patients Living with Severe Type 3 von Willebrand Disease (VWD)
- U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome
February 1, 2022
February 8, 2022
February 9, 2022
February 17, 2022
February 25, 2022
March 7, 2022
March 11, 2022
March 16, 2022
- Now Available Over the Counter, Lastacaft Provides Eye Allergy Itch Relief in Minutes that Lasts Through 16 Hours
- Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
March 21, 2022
March 24, 2022
March 28, 2022
- Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic 2 mg Providing Increased Glycemic Control for Adults with Type 2 Diabetes
- Fintepla (fenfluramine) Oral Solution Now FDA Approved for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)
March 29, 2022
March 30, 2022
April 1, 2022
April 25, 2022
- Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for Caplyta (lumateperone) for Specific Patient Populations
- Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19
April 28, 2022
April 29, 2022
- Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
- Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis
May 6, 2022
May 11, 2022
May 19, 2022
May 20, 2022
May 25, 2022
- Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
- United Therapeutics Announces FDA Approval of Tyvaso DPI
May 27, 2022
May 30, 2022
May 31, 2022
- FDA Approves Label Extension for Evrysdi for Infants with Spinal Muscular Atrophy Under 2 Months Old
June 1, 2022
June 7, 2022
- FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
- FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan (rituximab), for Adults with Moderate to Severe Rheumatoid Arthritis
June 8, 2022
June 13, 2022
June 16, 2022
June 17, 2022
June 22, 2022
June 23, 2022
June 24, 2022
June 27, 2022
July 8, 2022
- Pfizer and BioNTech Announce U.S. FDA Approval of Their COVID-19 Vaccine Comirnaty for Adolescents 12 Through 15 Years of Age
- FDA Approves Krystexxa (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy
July 14, 2022
July 18, 2022
July 27, 2022
July 29, 2022
August 1, 2022
August 3, 2022
August 5, 2022
- Myovant Sciences and Pfizer Receive U.S. FDA Approval of Myfembree, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis
- Calquence Tablet Formulation Approved in the US Across Current indications
- U.S. FDA Approves Additional Indication of Nubeqa (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
August 6, 2022
August 11, 2022
August 12, 2022
August 17, 2022
August 18, 2022
August 24, 2022
August 26, 2022
September 2, 2022
September 5, 2022
September 21, 2022
- Antiseizure Drug Diacomit Now Approved for Children as Young as 6 Months
- FDA Approves Lilly's Retevmo (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type
September 29, 2022
- Dupixent (dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis
- Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for Firdapse Expanding Patient Population to Include Pediatric Patients