Today, Astellas announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Biologics License Application (BLA) for zolbetuximab, a groundbreaking investigational monoclonal antibody targeting claudin…
The European Commission (EC) has granted marketing authorization, maintaining orphan designation, for QALSODY® (tofersen) to treat amyotrophic lateral sclerosis (ALS) in adults associated with a mutation in the superoxide dismutase…
Today, Takeda announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for treating…
Today, Pfizer released extended findings from the Phase 3 CROWN trial, examining the efficacy of LORBRENA® (lorlatinib), a third-generation ALK inhibitor, versus XALKORI® (crizotinib) in previously untreated patients with ALK-positive…
The U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory mantle…
Sanofi Launches Action 2024: Global Employee Shareholder Plan Sanofi’s global employee shareholder plan, Action 2024, opens on June 4, 2024, offering approximately 80,000 employees across 56 countries the opportunity to…
Sanofi to Appeal Delaware Court’s Decision on Zantac Sanofi has expressed disappointment with the recent decision by the State of Delaware court and intends to appeal. The company maintains that…
AbbVie announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of risankizumab (SKYRIZI®) for treating…
Imagine a contact lens that reshapes the cornea while you sleep, improving your vision. Picture wearing a contact lens equipped with technology to alleviate the strain from increased digital screen…
IGC Pharma Begins Patient Enrollment for Phase 2 Alzheimer’s Agitation Trial at Neurostudies IGC Pharma has commenced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its Phase 2…
A leader in Personalized Therapy Decision Support and Precision Drug Development, Cellworks, has announced the opening of a CLIA-certified computational laboratory in Franklin, Tennessee. Administered by the Centers for Medicare…
Be Biopharma Announces FDA Clearance for BE-101 IND Application in Hemophilia B Be Biopharma, Inc. (“Be Bio”), a pioneer in Engineered B Cell Medicines (BCMs), has announced the U.S. Food…