Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

Kashiv BioSciences secures Rs. 684 crore funding to build one of India’s largest biopharma facilities

The new single-use commercial facility will be among India’s largest, featuring advanced technologies to produce high-quality biologics and specialty pharmaceuticals

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.

Samsung Biologics strengthens U.S. presence with acquisition of GSK’s Human Genome Sciences or $280 million

Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification

Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids

The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities

Thermo Fisher opens Bioprocess Design Center in Hyderabad

Expands bioprocessing footprint across Asia

Halozyme wins German injunction blocking Merck’s Keytruda distribution

While Merck can appeal, Halozyme said it expects the order to hold

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor

Exyte completes Pharmaplan integration

Pharmaplan brings a pan-European footprint of locations and specialist teams, now operating within Exyte’s Biopharma & Life Sciences division

Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia

The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval

GSK's TESARO sues AnaptysBio over alleged breach of cancer drug licence deal

Croda partners with Amino to expand biopharma capabilities

The partnership combines Croda’s deep expertise in smart science and global market reach with Amino’s advanced capabilities in precision manufacturing of amino acids

ImmunoScape inks agreement with Cue Biopharma to launch next-gen cancer immunotherapy

The modular platform not only targets solid tumors but could also enhance traditional autologous and in vivo T cell therapies

Enzymit and Cosun chart breakthrough in cell-free hyaluronic acid production

Hyaluronic acid is among the world's most valuable biopolymers, with applications spanning from dermal fillers and wound healing to drug delivery and tissue engineering

Transition Bio and Voyager Therapeutics forge strategic collaboration to target ALS, FTD

The partnership aims to develop novel, selective small molecules targeting TDP-43 pathology

SpyGlass Pharma reports promising clinical trial results for glaucoma therapy

The data highlight sustained intraocular pressure (IOP) reduction, drop-free treatment outcomes, and strong visual performance

RedHill secures final $10.5M court judgment for enforcement

RedHill has obtained a court-approved asset attachment in South Korea to prevent Kukbo from transferring or disposing of assets ahead of enforcement of the judgment

Biostar Pharma doses first patient in Phase II/III multiregional trials of utidelone capsule