Earendil Labs bags $787m to supercharge AI-driven biologics pipeline

Capital infusion to accelerate Earendil’s R&D platform

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals

Envoy Medical secures three new patents, bolstering cochlear implant leadership

The new patents cover critical advancements in cochlear implant technology

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar

BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data

BridgeBio reports breakthrough results in Phase 3 achondroplasia trial

Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone

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.”

Roche BTK drug emerges as potential breakthrough in primary progressive MS

SMS Pharmaceuticals posts strong Q3 with 29% PAT growth, full-year targets on track

The company’s EBITDA margin remained resilient above 20%

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors