Divarasib monotherapy demonstrated superior efficacy over first-generation KRAS G12C inhibitors, lowering the risk of disease progression or death by 42% and the overall risk of death by 44%, in the phase III Krascendo 1 study1,2 At the time of primary analysis, divarasib achieved a median overall survival of approximately 18 months, compared to 12 months for sotorasib or adagrasib1,2 No new safety signals were observed with divarasib; the most common treatment-related adverse events were mainly

Pfizer scored a green light from the FDA on Monday to move its prostate cancer combination up earlier in the treatment paradigm. The US regulator approved PARP inhibitor Talzenna (talazoparib) plus androgen receptor pathway inhibitor Xtandi (enzalutamide) for patients with homologous recombination repair (HRR) gene-mutated metastatic hormone-sensitive prostate cancer (mHSPC), also known as androgen pathway modulation-naïve or -sensitive disease. The regulatory nod expands the regimen's label, i

Oct. 26, 2026 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) has been accepted for review by the China National Medical Products Administration (NMPA). The application is proposed to be sin

The first NMPA-approved anti-FcRn therapy to complete its full clinical development for gMG patients in China Oct. 22, 2026 -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced that the National Medical Products Administration (NMPA) of China has approved the Biologics License Application (BLA) for batoclimab injection (subcutaneous inj

EVX-01 induced an immune response in all patients in the trial with 89% of the vaccine neoantigens generating potent specific T-cell responses Three-year data from the EVX-01 phase 2 trial in patients with advanced melanoma to be presented at the ESMO 2026 Congress supplementing very convincing two-year data from the trial The data will be presented at a poster session on October 24, 2026, followed by a webinar on October 29, 2026, providing further insights into the findings October 23, 2026

In a 1L EGFR atypical population with more than double the rate of baseline CNS metastases as competitor datasets, enozertinib demonstrates a potential best-in-class 84% confirmed systemic ORR and 70% confirmed intracranial ORR, with multiple intracranial complete responses 88% 6-month landmark PFS compares favorably to current standards of care and to investigational therapies; follow-up ongoing with majority of patients continuing on treatment Competitive safety pro no significant off-target t

Gilead Sciences waded further into the immunology and inflammation (I&I) disease space on Thursday with the proposed purchase of PepStar Therapeutics' IL-23R inhibitor programme, which includes lead candidate HCXT-2001, in Phase I testing. The US drugmaker is splashing $1.28 billion in upfront cash to gain the asset, an oral macrocyclic peptide inhibitor of IL-23R with an extended half-life. The acquisition is expected to close this quarter. According to Gilead, IL-23R is a clinically validated

Rapport Therapeutics plans to move its experimental drug RAP-219 into Phase III development for a second indication following positive results from a mid-stage study for the treatment of bipolar mania. The news, announced Tuesday, sent the company's shares up as much as 27% in pre-market trading. RAP-219 is a TARPγ8-specific AMPA receptor (AMPAR) negative allosteric modulator (NAM) that Rapport believes offers pipeline-in-a-product potential due to the role of AMPA biology in various neurologic

Oral HBI-8000 plus intravenous nivolumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with nivolumab alone, reducing the risk of disease progression or death by 27% Median progression-free survival was 11.7 months with HBI-8000 plus nivolumab compared with 7.4 months with nivolumab alone The safety profile of HBI-8000 was consistent with experience from its use in more than 112,000 patients treated in other cancers If approv

Alcon on Wednesday spent $550 million to acquire Neurotech Pharmaceuticals, gaining its encapsulated cell therapy for macular telangiectasia type 2 (MacTel), a rare eye disease where blood vessels in the macula become dilated and leak, causing central vision loss. Encelto (revakinagene taroretcel-lwey) was greenlit in the US last year, making it the only FDA-approved treatment for MacTel. After surgical intravitreal implantation, the therapy continuously releases recombinant human ciliary neurot