Biogen has earned a positive CHMP opinion for its high-dose nusinersen regimen, supported by strong DEVOTE study results showing major motor improvements and reduced mortality risk in SMA patients.
Novo Nordisk has introduced a $199 introductory price for Wegovy and Ozempic starter doses, alongside a permanent drop in monthly self-pay costs to $349.
J&J is acquiring Halda Therapeutics for $3.05B, gaining a precision prostate cancer therapy and a breakthrough induced-proximity platform.
ABL Bio has signed a major license and research collaboration with Eli Lilly worth up to $2.602 billion, granting access to its Grabody bispecific platform.
Merck’s $9.2 billion acquisition of Cidara brings CD388, a Phase 3 long-acting influenza antiviral, into its pipeline while adding the Cloudbreak® drug-Fc conjugate platform for future oncology and infectious-disease programs.
Spanish health official displays a Ministry of Health certificate for asbestos-related injury, as Spain rolls out its new national certification system alongside expanded neonatal screening reforms. (Editorial illustration.) CISNS approves sweeping updates to neonatal diagnostics and formalizes a nationwide system to certify asbestos-related disease for compensation Spain’s Interterritorial Council of the National Health System (CISNS) … Read more
FDA officials Vinay Prasad and Marty Makary have unveiled a new “plausible mechanism pathway” designed to accelerate bespoke gene-editing therapies.
Eli Lilly has signed back-to-back collaborations with SanegeneBio and MeiraGTx, advancing its genetic medicine portfolio across RNA interference and ophthalmic gene therapy. Together, the agreements deepen Lilly’s position in next-generation RNA- and DNA-based therapeutics.
Sweden’s TLV has published its health economic assessment of Merck’s Keytruda for locally advanced cervical cancer, finding clear efficacy benefits when added to chemoradiation. However, the agency warns that cost-effectiveness hinges on price transparency and real-world survival durability.
Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more