Autolus Therapeutics has secured US Food and Drug Administration (FDA) approval for Aucatzyl (obecaktagene autoleucel), its ...

Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with ...

Syncona Shs GBP (GB:SYNC) has released an update. Syncona’s portfolio company, Autolus Therapeutics, has received FDA approval for AUCATZYL®, a ...

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung ...

Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Diltiazem Hydrochloride ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem ...

Alembic Pharmaceuticals Limited announced today it has received final approval from the US Food & Drug Administration (USFDA) ...

Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA, it added.

Compounded versions of semaglutide, the active ingredient in approved diabetes and obesity drugs Ozempic and Wegovy, have ...

US regulators gave the green light to Autolus Therapeutics’ cell therapy for adult B-cell precursor acute lymphoblastic leukemia, or B-ALL, that has returned or is not responding to prior treatment ...

In other words, if a drug is patented in Canada and is first approved for sale in the US, a company that plans to market the ...

Acute kidney injury is being redefined as a collection of syndromes, each of which could be targeted by specific biomarkers.