FDA Approvals Summary - July 2025FDA Drug ApprovalsFDA approved several new drugs in July 2025, including treatments for phenylketonuria, chronic hand eczema, hereditary angioedema, EGFR-mutated lung cancer, and relapsed multiple myeloma, offering new hope for patients.
First Global DPP1 Inhibitor Approved by FDAFDAThe FDA has approved brensocatib, the world’s first DPP1 inhibitor, for treating non-cystic fibrosis bronchiectasis in patients aged 12+, marking a breakthrough in targeted respiratory therapies.
Just In! FDA Officially Announces New CDER Dire?ctorFDADr. George Tidmarsh, biotech leader and Horizon Therapeutics founder, named FDA CDER Director. Discover what this means for drug development, regulation, and innovation. Stay updated with Guidechem’s expert insights.
FDA Reconsiders Elevidys Amid Safety ConcernsFDAThe FDA is reevaluating Sarepta's gene therapy Elevidys after a third patient death linked to its treatments. The agency may halt shipments amid rising safety concerns and market fallout.
FDA Approvals Summary - June 2025FDA Drug ApprovalsExplore FDA-approved new drugs from June 2025, including breakthroughs for hereditary angioedema, lung cancer, RSV, HIV prevention, bladder cancer, and rare diseases.
FDA Probes Sarepta's Elevidys After Second DeathFDAThe FDA is investigating Sarepta’s gene therapy Elevidys after two patient deaths linked to acute liver failure, raising safety concerns and prompting regulatory review.
Nuvation Bio's Ibtrozi Gains FDA Nod to Compete in Lung Cancer MarketFDANuvation Bio’s Ibtrozi (taletrectinib) secures FDA approval for treating ROS1-positive non-small cell lung cancer, offering a next-gen alternative to Pfizer, BMS, and Roche therapies with strong efficacy and CNS safety.
FDA Puts Gilead’s HIV Combo Trials on HoldGileadThe FDA has paused five Gilead HIV combo trials over safety concerns, but the decision does not impact lenacapavir's upcoming PrEP approval. Gilead remains confident in its HIV pipeline and future plans.
FDA Narrows Use of PD-1 Drugs in GI CancersFDAThe FDA has restricted Merck’s Keytruda and BMS’s Opdivo for use only in PD-L1-positive gastric, GEJ, and esophageal cancers, citing limited benefit in PD-L1-negative patients based on recent trial data.
