Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026

Feedback Medical brings Bleepa to India

Announces pilot project for rapid, remote diagnosis of tuberculosis

Holborn Wells and SpeedBio India forms JV to manufacture in vitro diagnostics

Both parties are expected to invest a total of US $ 1 million to establish the brand

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Lonza posts CHF 6.5 billion in 2025 sales, marks strong profit growth

Excluding Vacaville-related business, organic CER sales growth reached the low-teens with improved CORE EBITDA margins, in line with Lonza’s CDMO Organic Growth Model

Fides launches imaging CRO focused on early-phase clinical decision-making

Fid?s brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors

Vetter advances next-gen syringe closure system towards 2027 launch

The updated closure system introduces intuitive handling, innovative functionality and a premium design compatible with a wide range of syringe formats

FDA endorses Relmada’s registrational strategy for bladder cancer therapy