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3486 News Found

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia


Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch
News | December 21, 2025

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026


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,


Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU


Groundbreaking study identifies 250 genes driving ME & long COVID
R&D | December 08, 2025

Groundbreaking study identifies 250 genes driving ME & long COVID

76 of 180 long COVID-associated genes also linked to ME


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


Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case
News | December 02, 2025

Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case

At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits


FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels