1. Major Regulatory Approvals & Clinical Advancements
BMS wins landmark FDA approval for first CAR-T in Marginal Zone Lymphoma
On 4 December, the US FDA approved Breyanzi (lisocabtagene maraleucel) as the first CAR-T cell therapy for relapsed or refractory marginal zone lymphoma. This provides a much-needed option for patients who have failed at least two prior systemic therapies and reinforces the expanding role of CD19-directed cell therapies in indolent lymphomas.
Jaypirca (pirtobrutinib) secures full FDA approval for CLL/SLL
The FDA granted traditional approval to Eli Lilly’s Jaypirca for adults with relapsed or refractory CLL/SLL, following positive results from the pivotal BRUIN-CLL-321 trial. The decision strengthens the BTK inhibitor category for heavily pretreated populations.
FDA approves Axogen’s AVANCE nerve scaffold for sensory nerve repair
A breakthrough in regenerative medicine came with the 3 December approval of AVANCE, the first acellular nerve allograft scaffold approved for sensory nerve discontinuities up to 25 mm. It also carries accelerated approval for motor and mixed nerve gaps >25 mm, marking a major step for reconstructive surgery.
Promising Phase 3 data for Capricor’s Deramiocel in Duchenne Muscular Dystrophy
Capricor reported positive topline Phase 3 HOPE-3 results, showing Deramiocel (CAP-1002) slowed skeletal muscle decline and maintained cardiac function. The therapy positions itself as a potential first-in-class cell therapy for DMD cardiomyopathy.
WHO adds 12th mpox PCR kit to Emergency Use Listing
WHO granted Emergency Use Listing for the Bioperfectus MPXV PCR kit, expanding reliable global diagnostic capacity amid ongoing multi-country mpox surveillance needs.
EMA recommends approval for first recombinant EHD vaccine for cattle
The EMA’s CVMP issued a positive opinion for Laboratorios Syva’s Epizootic Haemorrhagic Disease recombinant vaccine, aimed at cattle serotype 8—timely as the disease continues its spread across Southern Europe.
2. Digital Health & Policy Developments
FDA launches TEMPO digital health pilot
In collaboration with CMS, the FDA introduced TEMPO, a first-of-its-kind pilot intended to accelerate access to chronic disease digital solutions. The program will evaluate real-world performance of innovative, uncleared technologies as part of the broader CMS ACCESS framework.
3. Strategic Partnerships & Product Launches
Takeda closes major global oncology licensing deal with Innovent
Takeda finalized its US$1.2B+ strategic collaboration with Innovent, gaining global rights (ex-China) to two late-stage assets: IBI363 (bispecific immunotherapy) and IBI343 (ADC for gastric & pancreatic cancers). The partnership includes co-development and US co-commercialization, strengthening Takeda’s oncology pipeline.
Rentschler Biopharma & Coriolis Pharma announce integrated CDMO partnership
A new collaboration between Rentschler and Coriolis aims to provide end-to-end biologics development—from formulation to commercial manufacturing—offering a smoother path for biotech firms managing complex biologic programs.
Sagent partners with Provepharm to launch Bludigo® in the US
Sagent announced the US launch of Bludigo® (indigo carmine injection), the first and only FDA-approved indigo carmine diagnostic dye, through a new partnership with Provepharm. The product supports intraoperative ureter visualization and expands Sagent’s specialty injectable portfolio.
