FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US

Lupin launches Bumetanide Injection USP in US

Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI