head and neck squamous cell carcinoma (HNSCC)
Oct 14, 2025
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade Boehringer Ingelheim’s JASCAYD (nerandomilast) has received FDA approval as an oral treatment for adults with idiopathic pulmonary fibrosis (IPF), marking the first new therapy for the condition in over a decade. JASCAYD is the first and...
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Mar 04, 2025
PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment
FDA Grants Priority Review to Precigen’s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec†), an investigational AdenoVerse gene therapy for adults with recurrent respiratory pa...
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Jul 26, 2022
VistaGen’s PH94B for Anxiety Disorder; Keytruda for Head and Neck Cancer Treatment; Bavarian Nordic’s Smallpox Vaccine Imvanex; CAMP4 Raises USD 100 Million; Incyte’s WU-CART-007; Incyte’s Opzelura for Vitiligo; AstraZeneca and Merck’s Lynparza; Sumitomo Pharma’s DSP-0390 for Brain Cancer
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...
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