Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

Biocon inks agreement for Ozempic commercialization in Brazil with Biomm

Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA

SPARC announces results from planned interim analysis of PROSEEK Study

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial

EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes

This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia

MTD acquires Ypsomed's pen needle and BGM businesses

This acquisition enables MTD to open new, strategic markets

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations

EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer

Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results