Non-small cell lung cancer
Aug 19, 2025
Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis; Tonix’s Tonmya Becomes First FDA-Approved Fibromyalgia Treatment in Over 15 Years; FDA Extends BLA Review for REGENXBIO’s RGX-121 in MPS II Patients; SystImmune’s Izalontamab Brengitecan (EGFRxHER3 ADC) Gets FDA Breakthrough Designation for EGFR-Mutated NSCLC; Soligenix Granted FDA Orphan Drug Status to SGX945 for Behçet’s Disease Therapy Following Phase II Success
Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The decision makes PAPZIMEOS the first and on...
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Aug 12, 2025
Teva’s AJOVY Expanded by FDA as First Anti-CGRP Preventive for Pediatric Episodic Migraine; NRx Pharma’s NRX-100 Granted FDA Fast Track for Suicidal Ideation in Depression/Bipolar Depression; Boehringer Ingelheim’s HERNEXEOS Wins FDA Accelerated Approval for HER2-Mutant Advanced NSCLC; Genmab’s Phase III EPCORE FL-1 Meets Dual Endpoints in Relapsed/Refractory Follicular Lymphoma; Tiziana’s Phase II IND Cleared by FDA for Multiple System Atrophy
FDA Expands Teva’s AJOVY As First Anti-CGRP Preventive For Pediatric Episodic Migraine Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the FDA has approved AJOVY (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescents aged 6–...
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Jul 29, 2025
Ascendis Pharma’s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency; Apellis Wins FDA Approval for EMPAVELI in C3G and IC-MPGN Treatment; FDA Approves PTC Therapeutics’ Sephience for Phenylketonuria; MAIA Biotechnology’s Ateganosine Gets FDA Fast Track for Non-Small Cell Lung Cancer; Entera Bio Gets FDA Nod on BMD as Primary Endpoint for Phase III Osteoporosis Study
Ascendis Pharma’s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency Ascendis Pharma A/S announced that the FDA has approved SKYTROFA (lonapegsomatropin-tcgd) for the treatment of adult growth hormone deficiency (GHD). Already approved for pediatric GHD since 2021, SKYTROFA is a once-weekly prodrug of ...
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May 20, 2025
Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+
Incyte’s ZYNYZ Approved by FDA as First-Line Treatment for Advanced Anal Cancer The FDA approved ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor developed by Incyte, for the treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The approval incl...
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May 09, 2025
ADCs in Lung Cancer Treatment: ENHERTU’s Rise, HER3 & TROP-2 Challenges, and What’s Next in the Pipeline
Lung cancer remains the leading cause of cancer-related death in the United States; approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), with ~530K cases in the 7MM. The main subtypes of NSCLC are adenocarcinoma (~57%), squamous cell carcinoma (~26%), and large cell carcinoma (~2%). Despite adv...
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Apr 29, 2025
Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47
Boston Scientific Pushes Forward Despite $200M Tariff Challenge Boston Scientific has announced that tariffs are expected to add approximately $200 million to its costs this year, but the company remains confident in its ability to absorb the financial hit. Despite the tariff burden, the company reported robust ...
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Apr 28, 2025
European Lung Cancer Congress (ELCC) 2025 Recap: Advances in Lung Cancer Research and Treatment
The European Lung Cancer Congress (ELCC) 2025, which took place in Paris from March 26-29, 2025, brought together lung cancer experts who presented the most anticipated clinical results. The three days served as an essential platform for exchanging valuable insights and fostering connections within the lung cancer ...
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Mar 28, 2025
8 Emerging Bispecific Antibodies Transforming NSCLC Treatment
Non-small cell lung cancer (NSCLC) remains one of the toughest cancers to treat, but bispecific antibodies (BsAbs) are changing the game. Unlike traditional therapies, BsAbs are engineered to target two different antigens simultaneously, enhancing precision and boosting immune response. This dual-targeting approach...
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Dec 31, 2024
FDA Approves Opdivo Qvantig™ for Solid Tumors; Nuvation Bio’s Taletrectinib NDA Accepted for ROS1-Positive NSCLC; HKBU’s Aptamer for X-Linked Hypophosphatemia Gets FDA Orphan Designation; Sapience’s ST316 Receives FDA Orphan Status for FAP; Precigen Submits BLA for PRGN-2012 in RRP
FDA Approves Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) for Subcutaneous Use in Adult Solid Tumors Bristol Myers Squibb has received FDA approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. This innovative product is a combination of nivolumab and recombin...
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Dec 16, 2024
Merus’ BIZENGRI: The New Face of NRG1+ Cancer Treatment After FDA Approval
Merus had a standout start this month. Shortly after landing a long-anticipated commercialization partner for its zenocutuzumab, the drug has achieved FDA approval, becoming the first therapy to target cancers with a neuregulin 1 (NRG1) gene fusion. The FDA granted accelerated approval to the drug, now marketed ...
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