Non-Small Cell Lung Cancer (NSCLC)
Sep 09, 2025
NeuroNOS’ BA-101 Granted FDA Orphan Drug Status for Glioblastoma; Takeda’s VONVENDI Approval Expanded for Von Willebrand Disease in Adults and Children; Telix Gains FDA Nod on Resubmission Pathway for TLX101-CDx NDA; Saol Therapeutics Receives FDA CRL for SL1009 in Pyruvate Dehydrogenase Complex Deficiency; FDA Grants Breakthrough Therapy Designation to Boehringer’s HERNEXEOS for HER2-Mutant Advanced NSCLC
NeuroNOS Secures FDA Orphan Drug Designation for BA-101 in Glioblastoma NeuroNOS, a biopharmaceutical company specializing in neurological disorders and neuro-oncology and a subsidiary of Beyond Air, announced that the FDA has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-101, for...
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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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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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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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Nov 29, 2024
Evaluating Key Advancements and Emerging Therapies in EGFR-Non Small Cell Lung Cancer Treatment Market
Non-small cell lung cancer (NSCLC) is the most common cancer, accounting for approximately 85% of the total lung cancers in the United States. Almost 500K cases in the 7MM were diagnosed in 2022 alone. Moreover, significant deaths were recorded at the end of the same year. Analysis indicates that the most common ge...
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Nov 29, 2024
The Next Chapter in NSCLC Treatment Space: Recent Discoveries and Innovations
Lung cancer was the most prevalent cancer globally, with 2.5 million new cases, representing 12.4% of all new cancer diagnoses. NSCLC is the most common type of lung cancer, accounting for over 85% of all cases. As per the latest estimates, the total incident cases of NSCLC in the 7MM were approximately 500K cases ...
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Jul 09, 2024
Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval
Lilly Strengthens IBD Treatment Portfolio with Morphic Acquisition Eli Lilly and Company and Morphic Holding, Inc. announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for serious chronic diseases. Lilly will initiate a tender offer to acqu...
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Apr 15, 2024
ENHERTU: Another Triumph to Celebrate for AstraZeneca and Daiichi Sankyo
ENHERTU lies at the core of AstraZeneca and Daiichi Sankyo’s objectives for advancing in oncology. This collaboration has notably broadened the antibody-drug conjugates impact in the United States. On April 5, 2024, the FDA approved ENHERTU to treat HER2-positive solid tumors in adults who have received previous sy...
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