AI is Transforming Drug Safety—But Governance Sets Essential Guardrails

artificial intelligence; drug safety; pharmacovigilance; adverse drug events; regulatory governance; FDA; EMEA; AI guardrails; data integrity; bias; patient safety

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

Zenas BioPharma Inks $2 Billion+ Licensing Deal With InnoCare for Autoimmune Drug Candidates

Zenas BioPharma; InnoCare Pharma; autoimmune diseases; multiple sclerosis; BTK inhibitor; orelabrtuinib; licensing deal; clinical trials; IL-17 inhibitor; TYK2 inhibitor

CDC Updates COVID-19 and Chickenpox Vaccine Guidance Based on ACIP Recommendations

CDC; COVID-19 vaccine; chickenpox vaccine; ACIP; individual-based decision-making; MMRV; varicella; immunization schedule; febrile seizure

NanoPhoria Secures €83.5M Series A for Heart Failure Therapy; AstraZeneca and Algen Ink Up to $555M AI Drug Discovery Pact

NanoPhoria; Series A; heart failure; NP-MP1; nano-in-micro delivery; AstraZeneca; Algen Biotechnologies; AI drug discovery; immunology; CRISPR; gene modulation; deal value

Legal Pressure Escalates as FDA Intensifies Crackdown on Direct-to-Consumer Pharma Advertising

FDA enforcement; direct-to-consumer advertising; pharmaceutical advertising crackdown; warning letters; legal challenges; AI monitoring; prescription drug ads; transparency in advertising; HHS; compounding pharmacies

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke