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1522 News Found

Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US


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


Kytopen & TQ Therapeutics forge partnership to advance next-generation cell therapies
Technology | December 04, 2025

Kytopen & TQ Therapeutics forge partnership to advance next-generation cell therapies

The partnership aims to combine TQx’s in vivo therapeutic expertise with Kytopen’s continuous flow transfection technology


Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome
Biopharma | December 04, 2025

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor


FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Drug Approval | December 04, 2025

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor


Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Clinical Trials | December 04, 2025

Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

The company is excluding data from the affected sites to maintain the study's integrity


Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt
Clinical Trials | December 03, 2025

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data


Merck unveils first human data for Alzheimer’s candidates
Clinical Trials | December 03, 2025

Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration


Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease
Clinical Trials | December 03, 2025

Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease

Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss


AbbVie’s Atogepant shows breakthrough results for acute migraine relief
Clinical Trials | December 03, 2025

AbbVie’s Atogepant shows breakthrough results for acute migraine relief

Suffering from acute migraine? You may soon bid adieu to the debilitating headache