Recon: FDA reviewers flag eye risks with GSK’s blood cancer therapy; FDA ends import screening exemption for low-value goods
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA staff flags eye safety risks for GSK's blood cancer drug (Reuters)
- The end of animal testing? Transitioning to models is promising — but no silver bullet (STAT)
- Weight-loss drug use in kids surged after doctors' recommendation (Axios)
- The Trump administration disbanded a newborn screening panel. Advocates now face a harder path (Endpoints)
- FDA employees let go in April receive final termination notices (Endpoints)
- HHS Formally Lays Off Employees Following Supreme Court Ruling (Bloomberg)
- Judge rejects AbbVie’s fight against Missouri 340B contract pharmacy law (Endpoints)
- FDA chief calls for lower user fees as negotiations begin for eighth round of PDUFA (Endpoints)
- Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII (Pink Sheet)
- FDA to screen all imports, exemptions for low-value shipments revoked (Reuters)
- After Phase 3 obesity success, Hengrui plans China approval filing for Kailera-partnered drug (Endpoints)
- Global childhood vaccination shows slight improvement but challenges remain (Reuters)
- Sino Biopharmaceutical to acquire LaNova Medicines for up to $951 million (Reuters)
- Anthem Biosciences' $395 million IPO fully subscribed as investors bet on Indian pharma (Reuters)
- ViiV expands license to allow generic HIV treatment production for low-income countries (Reuters)
- Kailera touts late-stage win for weight-loss drug in China (Reuters)
- Indira IVF Said to Revive India IPO That May Raise $408 Million (Bloomberg)
- Vaccination Rates Lag in Europe as Measles Cases Rise, WHO Says (Bloomberg)
- SpaceX Plans Starship Program for In-Orbit Drug Research (Bloomberg)
- An AstraZeneca Exit Wouldn’t Doom London (Bloomberg)
- How Hims Became the King of Knockoff Weight-Loss Drugs (Bloomberg)
- Bayer's Kerendia wins FDA label expansion to treat 2 types of heart failure (Fierce Pharma)
- Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test (MedTech Dive)
- Zimmer agrees to distribute Getinge products to expand ASC offering (MedTech Dive)
- Zimmer to buy robotics firm Monogram for about $177M (MedTech Dive)
- Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs (MedTech Insight)
- FDA approves natural blue color, urges accelerated phaseout of synthetic red dye (Food Dive)
- US ice cream makers commit to artificial dye phase-out by 2028 (Food Dive)
- Study finds no evidence aluminum salts in vaccines are tied to higher risk of asthma, other childhood diseases (STAT)
- After long saga, 23andMe's deal with Anne Wojcicki's nonprofit finally closes (Endpoints)
- West Virginia abortion ban upheld over drugmaker's challenge (Reuters)
- Ex-Pfizer Doctor Tells Congress He Didn’t Delay Covid Shot Data (Bloomberg)
- Stealth Stake Sales Helped UnitedHealth Beat Wall Street Targets (Bloomberg)
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