FDA Authorizes Generic Nitenpyram for New World Screwworm in Dogs and Cats
FDA issues Emergency Use Authorization for generic Nitenpyram Tablets to treat New World screwworm infestations in dogs and cats weighing at least two pounds.
RegulatoryFDA Expands Sunscreen Options for the First Time in 20 Years
FDA adds bemotrizinol to approved sunscreen ingredients, the first new active sunscreen ingredient in 20 years, used safely in Europe for decades.
RegulatoryEMA, AMA and African Regulators Join Forces on Ebola Outbreak Response
EMA's Emergency Task Force collaborates with AMA and African regulators to advance clinical trials and medical countermeasures for the Bundibugyo Ebola outbreak in the DRC and Uganda.
RegulatoryANVISA Updates Health Measures for Ports and Airports Amid Ebola Outbreak
Brazilian Health Regulatory Agency updates port and airport health protocols after WHO declares Ebola outbreak in Congo a Public Health Emergency of International Concern.
RegulatoryFDA Issues Draft Guidance to Accelerate Cell and Gene Therapies for Patients
FDA draft guidance proposes leveraging existing platform knowledge to streamline development of cell and gene therapies for rare and life-threatening diseases.
RegulatoryETF Recommends Updating COVID-19 Vaccines to Target XFG Variant
EMA's Emergency Task Force recommends updating COVID-19 vaccines to target the XFG variant for the 2026/2027 vaccination campaign.
RegulatoryFDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
FDA draft guidance aims to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs, potentially accelerating timelines for human trials.
RegulatoryEU recommendations for 2026/2027 seasonal flu vaccine composition
Annual updates to virus strains ensure vaccines stay effective
RegulatoryEMA Recommends First Oral GLP-1 Treatment for Weight Management
EMA recommends first oral GLP-1 (semaglutide) for weight management, offering Wegovy tablets as an alternative to injections.
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