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
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
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
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