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WuXi XDC Grants Exclusive Global License for WuXiTecan-2 Platform in USD 885 Million Pact
WuXi XDC Cayman Inc., a global CRDMO specializing in antibody-drug conjugates (ADCs) and other bioconjugates, has entered into a strategic collaboration with Earendil Labs to advance next-generation ADC development.
EMA Panel Backs Norgine?s XOLREMDI for WHIM Syndrome Under Exceptional Circumstances
The EMA’s CHMP recommends marketing authorisation for XOLREMDI (mavorixafor) to treat WHIM syndrome patients aged 12 and above, marking a major step toward the first licensed therapy for the rare disorder.
XellSmart Secures Fourth FDA and NMPA Clearance for iPSC-Derived Cell Therapy Targeting MSA-P
XellSmart receives US FDA and China NMPA clearance for Phase I/II trials of its iPSC-derived neuron progenitor therapy for MSA-P, expanding its CNS pipeline spanning PD, ALS and spinal cord injury.
Ultrasound AI Secures FDA De Novo Clearance for Delivery Date AI Technology
FDA grants De Novo clearance to cloud-based Delivery Date AI, enabling real-time predicted delivery dates from standard ultrasound images to support clinical decisions in pregnancies with uncertain dating.
Pfizer Chief Criticises FDA Vaccine Unit Leadership and Decision-Making
Pfizer Chief Executive Officer Albert Bourla has publicly raised concerns about the leadership of the US Food and Drug Administration’s vaccine and biologics division, citing internal discord and recent regulatory decisions as problematic.
Strategic Licensing Boost: Emcure Gains Commercial Rights for Roche Brands in India
Under the agreement, Emcure will acquire commercial rights to several branded prescription medicines used in the management of kidney diseases and in post-transplant care for patients in India. The deal strengthens Emcure’s presence in high-priority therapeutic areas and expands its portfolio in nephrology and transplant medicine.
IceCure Medical Study in PLOS One Highlights ProSense Cryoablation for Benign Breast Tumours
Independent Hungarian study shows ProSense cryoablation achieves up to 92.9 percent tumour reduction in fibroadenomas, supporting minimally invasive alternatives to surgery for benign breast lesions.
SciBase Holding AB Secures US FDA Approval to Expand Nevisense Use Beyond Dermatologists
U.S. Food and Drug Administration clears expanded labelling for Nevisense, enabling trained healthcare professionals to perform procedures, improving clinic workflow integration and supporting broader melanoma diagnostic access across the United States.
Indian Scientists Redefine 50-Year-Old Biological Principle
For nearly 50 years, biology has related the story of how bacteria turn their genes on with the help of the so-called “σ (sigma) cycle” – factors that bind RNA polymerase to initiate transcription and then dissociate to allow elongation. This concept was built largely on observations of bacterial strain E. coli σ70.
Dr Jitendra Singh Proposes India-Delaware Biomanufacturing Working Group
Dr Jitendra Singh proposed an India-Delaware Biomanufacturing Working Group to boost biotech collaboration, highlighting startup and R&D linkages. He also stressed supply chain resilience and regulatory cooperation during India-US talks to strengthen innovation, manufacturing and strategic life sciences ties.
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