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

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years

Sanofi invests €40 million to strengthen antibody bioproduction in France

Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma

Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex

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

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial

Bristol Myers Squibb showcases cardiovascular portfolio at AHA Scientific Sessions 2024

Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS

AbbVie provides update on Phase 2 results for Emraclidine in schizophrenia

Emraclidine was well-tolerated with an adverse event profile consistent with Phase 1b trial

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

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