Atopic dermatitis

After a few days of investor anxiety, Arcutis Biotherapeutics announced that the FDA has approved ZORYVE for a new indication: atopic dermatitis. The FDA was scheduled to announce its decision on ZORYVE (roflumilast) for this new use on the 7th of this month, but the date passed without news. In an uncommon move to...

Immutep Announces Promising Outcomes for First-Line Treatment in PD-L1 Negative Head and Neck Squamous Cell Carcinoma Patients Immutep Limited announced positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, evaluating eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy KEYTR...

IMDELLTRA Receives FDA Approval as the First T-Cell Engager Therapy for Advanced Small Cell Lung Cancer Amgen has reported that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following pl...

Atopic dermatitis is common worldwide, and people of all ages, from newborns to adults 65 and older, live with this condition. The World Health Organization (WHO) Global Burden of Diseases initiative estimates more than 230 million people globally have atopic dermatitis and that skin diseases are the fourth leading...

AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type Asklepios BioPharmaceutical, Inc., a gene therapy firm fully owned and independently operated under Bayer AG, announced the initiation of the Phase I REGENERATE MSA-101 clinical trial ...

FDA Approves Incyte’s Opzelura as First Vitiligo Therapy The US Food and Drug Administration has approved Incyte’s Opzelura cream 1.5% for the topical treatment of non-segmental vitiligo in adult and paediatric patients 12 years of age and older. With this approval, Opzelura is the first and only FDA-approved...

GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.&...

Dupixent (dupilumab) is a non-immunosuppressive fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. According to data from Dupixent clinical trials, IL-4 and IL-13 are key drivers of type 2 inflammation, which is a major contributor to Atopic...

Immunocore Receives FDA Approval for the First Uveal Melanoma Treatment, As Well As the First T-cell Receptor Therapeutics Uveal Melanoma, an aggressive eye cancer, has proven to be a tough nut to crack for researchers seeking a cure. However, with the approval of a new treatment, those with the disorder will ha...

Although COVID-19 continued to dominate headlines in 2021, pharmaceutical companies did not cease developing new treatments this year. The US Food and Drug Administration maintained a rapid rate of new drug approvals this year, all while managing the urgent examination of COVID-19 tests, treatments, and vaccines un...