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
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
76 of 180 long COVID-associated genes also linked to ME
The partnership aims to combine TQx’s in vivo therapeutic expertise with Kytopen’s continuous flow transfection technology
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
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
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