ORDINAL
Biopharma Industry Braces for Uncertainty Under Trump’s Second Term: Impact on Vaccines and M&A Deals
Trump’s second term, Biopharma industry, Vaccine regulation, Robert F. Kennedy Jr., M&A deals, FTC policy changes, Healthcare policy uncertainty
Novartis Secures First-Line Approval for Scemblix in Newly Diagnosed Chronic Myeloid Leukemia Patients
Scemblix, Novartis, first-line approval, chronic myeloid leukemia, CML, newly diagnosed, FDA approval
Fierce Pharma AsiaAstellas’ first-in-class FDA nod; Otsuka’s IgAN win; Samsung Bio’s $1.2B contract
United States Food and Drug Administration, IGA Glomerulonephritis, Sibeprenlimab, Contract agreement, Samsung, first
Jazz Pharmaceuticals Advances Combination Therapy for Extensive-Stage Small Cell Lung Cancer
Jazz Pharmaceuticals, Zepzelca, lurbinectedin, atezolizumab, ES-SCLC, first-line maintenance therapy, small cell lung cancer, Phase 3 IMforte trial
FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues
Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues
Sarclisa Gains FDA Approval as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Sarclisa, FDA approval, first-line treatment, multiple myeloma, Sanofi, isatuximab, VRd combination therapy.
Bristol Myers Advances Opdualag into Phase 3 Trials for First-Line Lung Cancer
Opdualag, Bristol Myers Squibb, lung cancer, first-line treatment, phase 3 trials, LAG-3/PD-1 combination therapy
F2G Secures $100M Funding for Second Attempt at FDA Approval for Novel Antifungal Drug Olorofim
F2G, antifungal drug, olorofim, FDA approval, funding, second attempt
Carisma Therapeutics to Lay Off Staff, Discontinue CAR-M Programs in Pursuit of Second Candidate
Carisma Therapeutics, Layoffs, Workforce reduction (37%), Dropping clinical CAR-M program, Anti-HER2 CAR-macrophage CT-0508, Anti-mesothelin CAR-monocyte candidate CT-1119, Second candidate focus
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo