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3326 News Found

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus
Clinical Trials | December 21, 2025

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation


Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity
Drug Approval | December 20, 2025

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,


SABIC launches first fluorine-free polycarbonate resin to boost medical device safety
Medical Device | December 19, 2025

SABIC launches first fluorine-free polycarbonate resin to boost medical device safety

The NP resin portfolio, indicated by its UL746G-certified prefix, equips manufacturers across industries to meet increasingly stringent regulatory and performance standards


FDA nod to first oral single-dose treatment for gonorrhea
Drug Approval | December 16, 2025

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership


UPM unveils world’s first carbon-negative, fully recyclable black pigment
Packaging | December 13, 2025

UPM unveils world’s first carbon-negative, fully recyclable black pigment

The innovation -- UPM Circular Renewable Black -- is the world’s first bio-based, near-infrared (NIR) detectable, carbon-negative black


FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer
Clinical Trials | December 12, 2025

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA


WuXi Biologics teams up with Qatar Free Zones Authority to launch first Middle East CRDMO Centre
R&D | December 09, 2025

WuXi Biologics teams up with Qatar Free Zones Authority to launch first Middle East CRDMO Centre

This collaboration sets the stage for WuXi Biologics’ first integrated CRDMO center in the region


Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment
Drug Approval | December 06, 2025

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation


Eurofins launches first GMP PFAS testing solution for medical devices
Medical Device | December 05, 2025

Eurofins launches first GMP PFAS testing solution for medical devices

Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates