Regulation or Law
2024 FDA Drug Approvals: Small Companies Make Significant Impact
FDA drug approvals 2024, small biotech companies, pharmaceutical industry, new drug approvals, regulatory updates.
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
Novo Holdings to Finalize $16.5B Acquisition of Catalent Following Regulatory Clearance
Novo Holdings, Catalent, Acquisition, Regulatory Clearance, Life Sciences, Pharmaceutical Development
Biotech Industry Prepares for Trump 2.0: Regulatory Changes and M&A Activity Expected
Biotech industry, Trump 2.0, FDA changes, M&A activity, regulatory environment, pharmaceutical industry, healthcare policy
Navigating JPM Week 2024: Insights and Opportunities in Biopharma
JPM Week 2024, Biopharma, Industry Insights, Networking, Deal-making, Investment, M&A, IPOs, Regulatory Trends
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
GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment
GSK, Linerixibat, PBC Itch, Phase 3 Trial, Regulatory Filings, Cholestatic Pruritus
Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions
Merck, Keytruda, subcutaneous, cancer immunotherapy, phase 3 trial, non-inferiority, regulatory submissions
RFK Jr.’s HHS Nomination: A Potential Threat to the Biopharma Industry
RFK Jr., HHS nomination, biopharma industry, vaccine skepticism, health policies, Trump administration
GSK’s Blenrep Demonstrates Survival Advantage Over J&J’s Darzalex in Multiple Myeloma Treatment
GSK, Blenrep, Belantamab mafodotin, Multiple myeloma, DREAMM-7, DREAMM-8, Darzalex, Survival advantage, Regulatory challenges