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FDA leadership shock after Marty Makary’s resignation
Marty Makary resigned as FDA commissioner, with Kyle Diamantas stepping in as acting commissioner. The change ends a tenure that reshaped biotech expectations around drug review processes,...
Rigel lands global rights to new PROTAC breast cancer drug Veppanu
Rigel Pharmaceuticals agreed a global licensing deal for Veppanu (vepdegestrant), the PROTAC breast cancer therapy newly approved by the U.S. FDA. The arrangement follows a commercialization...
Regulator signs off on Cepheid’s multiplex GI diagnostic under IVDR
Cepheid received CE marking under the EU In Vitro Diagnostic Regulation (IVDR) for its Xpert GI Panel, a syndromic multiplex PCR test for acute gastrointestinal pathogens. The panel detects 11...
Winship delivers first U.S. in vivo CAR-T dose in multiple myeloma trial
Physicians and researchers at Emory University’s Winship Cancer Institute administered the first investigational in vivo CAR-T cell therapy dose in the United States for relapsed or refractory...
New FDA accelerated approval for Beone’s sonrotoclax in mantle cell lymphoma
Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax, branded Beqalzi, gained U.S. FDA accelerated approval for patients with relapsed or refractory mantle cell lymphoma after treatment...
Pacific Edge raises NZ$25.4M amid Medicare push for bladder triage tests
Pacific Edge, a New Zealand diagnostics company developing urine molecular assays for urothelial and bladder cancer risk stratification, raised NZ$25.4 million via a share placement. The funding...
ApexGO uses iterative AI optimization to improve peptide antibiotics
Researchers at the University of Pennsylvania unveiled ApexGO, an AI method designed to optimize peptide antibiotic candidates starting from a small number of imperfect molecules. Rather than...
Iterative health scales clinical trial enrollment with $77M Series C
Iterative Health secured $77 million in a Series C round to scale its AI- and technology-enabled clinical trial site network across cardiology and obesity, and to expand globally. The company said...
Regulatory reshuffle at the FDA
Marty Makary resigned as U.S. FDA commissioner, with Kyle Diamantas stepping in as acting commissioner. The leadership change follows a period of internal turnover and industry concern about the...
Targeted protein degradation deal and commercialization of vepdegestrant
Rigel Pharmaceuticals secured a global licensing agreement for vepdegestrant (marketed as Veppanu) after Pfizer and Arvinas reduced their exposure to the estrogen-receptor bifunctional degrader....
Major pharma-to-pharma collaboration for early oncology and immunology programs
Bristol Myers Squibb and Hengrui Pharma expanded global drug discovery with a collaboration covering 13 early-stage programs across oncology, hematology, and immunology. The pact is valued at up...
FDA accelerated approval for sonrotoclax in mantle cell lymphoma
Beone Medicines’ sonrotoclax (Beqalzi) gained U.S. FDA accelerated approval for relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor. The approval marks the first...
Obesity drug maintenance strategy: switching from injectables to oral therapy
New clinical data presented at ECO 2026 and published in Nature Medicine suggest that weight loss achieved on injectable obesity therapies can be maintained by transitioning to oral treatment. The...
In-orbit manufacturing for pharmaceuticals
Varda Space Industries said it has signed up United Therapeutics for a commercial program to produce drug materials in microgravity. The plan is to launch versions of United’s drugs into orbit so...
Gene therapy platform safety signals and trial complexity
Reports out of the gene therapy ecosystem highlight complications around viral delivery risk and the trade-offs between immunosuppression and efficacy. One story describes how steroids commonly...
AI-driven antibiotic design that performs in lab and in vivo
University of Pennsylvania researchers disclosed ApexGO, an AI-guided method to optimize peptide antibiotics from a small starting set rather than screening massive candidate libraries. The...
Funding: large Series C expansion for Iterative Health
Iterative Health closed a $77 million Series C round to expand trial operations and accelerate enrollment. The company said it will deepen capabilities in cardiology and obesity trials, invest...
Diagnostics: expanded Medicare coverage and new CE-IVDR marking
Two diagnostics moves signaled regulatory and reimbursement progress for real-world adoption. Personalis’ NeXT Personal minimal residual disease assay won expanded Medicare coverage via MolDX for...
FDA leadership shakeup and regulatory uncertainty
The FDA said it will be reshaping leadership after Commissioner Marty Makary resigned, with Kyle Diamantas stepping in as acting commissioner. The transition follows a tumultuous period for...
Big pharma dealmaking: BMS and Hengrui expand global oncology and immunology pipeline
Bristol Myers Squibb (BMS) and Jiangsu Hengrui Pharma have agreed to collaborate on 13 early-stage programs across oncology, hematology, and immunology in a deal valued at up to $15.2 billion. The...