If at first you don’t succeed in gene therapy, then try, try again. That's the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos.

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squam

Aug. 21, 2026 -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY® (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea. ZEGFROVY is approved in China and the U.S.

Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma Pivotal Phase 3 SIGMA study enrollment underway Aug. 20, 2026 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safus

IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure Aug. 20, 2026 -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement

FDA raises no objection to the Company's planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages; IND submission remains on track for the fourth quarter of 2026 August 20, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based treatments for stress-related neuropsychiatric disorders, today announced that it has received written responses from the U.S. Food and Drug Administration (FDA) to its

IDEAYA entered into a clinical collaboration to evaluate IDE892, IDEAYA's potential best-in-class Phase 1 MTA-cooperative PRMT5 inhibitor, in combination with RG6620, Genentech's Phase 1 KRAS G12D inhibitor, in MTAP-deleted, KRAS G12D-mutant pancreatic ductal adenocarcinoma Genentech will sponsor the clinical trial, and there will be joint governance to oversee the study Aug. 19, 2026 -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery an

Aug. 19, 2026 -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's 68Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (ccRCC). 68Ga-NYM096 is the first China-originated innovative radiopharmaceuti

Biodexa announces major milestone for its Serenta registrational Phase 3 trial in FAP 87 subjects, over 50% of target, recruited Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (“Biodexa” or “the Company”), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has exceeded the half-way point in the recruitment of subjects in its registrational Phase 3 trial of eRapa in Familial Adeno

Financing led by Company K Partners with participation from SV Investment, Flexus Partners and existing investors Proceeds to support continued clinical development of novel oncolytic immunotherapy VET3-TGI KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, today announced the closing of a $14 million extension of its Series A financing. The financing was led by Company K Partners, with participat