Cogent advances third bezuclastinib FDA submission after APEX pivotal trial results
Cogent’s bezuclastinib NDA for advanced systemic mastocytosis is backed by APEX data showing 65% ORR and deep KIT-driven disease marker reductions.
Pharma & Biotech
Pharma & Biotech
Zambon’s Hopledo wins CHMP backing, but can fewer daily doses reshape Parkinson’s care?
See how Zambon’s Hopledo could change Parkinson’s motor fluctuation care in Europe after a positive CHMP opinion, and what risks remain.
Pharma & Biotech
Zura Bio bets on dual IL-17 and BAFF inhibition across three immune-mediated disease
Explore how Zura Bio’s expanded tibulizumab Phase 2 program could change treatment development in HS and systemic sclerosis.
Pharma & Biotech
Russell 2000 inclusion puts Precision BioSciences before more investors at a pivotal clinical stage
See how Russell 2000 inclusion expands Precision BioSciences’ investor reach while PBGENE-HBV and PBGENE-DMD face critical clinical tests.
Pharma & Biotech
Samsung Bioepis SB27 meets Phase 3 endpoint as Keytruda biosimilar competition accelerates
Read how Samsung Bioepis SB27’s positive Phase 1 and Phase 3 data could reshape the Keytruda biosimilar race and oncology access.
Pharma & Biotech
Covista links scholarships, clinical training and employment in Advocate Health nursing deal
Explore how Covista and Advocate Health’s nursing pipeline could reshape workforce readiness, retention and patient access across U.S. care.
Pharma & Biotech
Can Merck’s IDVYNSO agreement widen HIV treatment access across state programmes?
See how Merck’s IDVYNSO ADAP agreement could widen HIV treatment access while pricing, formularies and clinical limits shape uptake.
Pharma & Biotech
Natera and Aveta Biomics bring Signatera into APG-157 Phase 3 head and neck cancer trial
See how Natera’s Signatera could sharpen APG-157’s Phase 3 evidence in head and neck cancer and what risks remain. Read the analysis.
Pharma & Biotech
FDA expands Skyrizi to children as AbbVie introduces weight-based 55 mg dose
AbbVie has secured a broad pediatric label for Skyrizi, adding both plaque psoriasis and active psoriatic arthritis alongside a new dose for children weighing less than 40 kg. The approval could strengthen treatment choice, although the evidence supporting the two indications is not equally direct.
Pharma & Biotech
Sobi’s NASP FDA setback turns uncontrolled gout opportunity into a manufacturing test
The FDA has delayed NASP without raising clinical approvability concerns, shifting attention to manufacturing controls, contract facilities and Sobi’s resubmission strategy.