Recon: FDA approves first line indication for Boehringer’s lung cancer drug; FDA planning bonuses to staff for speedy drug reviews
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad (STAT)
- FDA to Give Staff Bonuses for Speeding Up Drug Reviews (Bloomberg) (Reuters)
- CDC vaccine advisors to consider COVID-19 vaccine injuries, long COVID (Reuters)
- Surgeon general nominee and senator face off over vaccines and ‘shared decision-making’ (STAT)
- The nation’s MAHA mom lands in Congress, with some uncomfortable questions (STAT)
- Rare disease advocates fume over FDA’s mixed signals (STAT)
- MDUFA VI Negotiations Focus on TAP Expansion, Fee Structures (Pink Sheet)
- Viatris plans to lay off up to 10% of staff, discloses Indian factory fire (Endpoints)
- Japanese conglomerate Asahi Kasei to buy German antiviral biotech Aicuris for $920M (Endpoints)
- Democratic Republic of Congo and US agree $1.2 billion strategic health partnership (Reuters)
- EU says social fund can be used to allow access to safe abortions across bloc (Reuters)
- Lilly’s GLP-1 pill beats Novo’s in diabetes trial, but has more side effects (Endpoints)
- US FDA approves first line use of Boehringer Ingelheim's lung cancer drug (Reuters)
- I tried to design a clinical trial for a supplement. 5 things got in the way (STAT)
- Sarepta Therapeutics CEO Doug Ingram will retire after a tumultuous decade (STAT)
- Xenon’s seizure drug study reads out soon. Here’s what to expect (STAT)
- Protagonist to opt out of Takeda profit-sharing deal, will receive $400M in cash (Endpoints)
- OrbiMed jumps to number one on the top 100 list of biotech venture investors (Endpoints)
- Exclusive: Salma Health raises $80M for its clinics to treat brain health (Endpoints)
- Brain implants: What’s standing in the way of pivotal trials, FDA approval (STAT)
- Why did my doctor push Grail’s dubious cancer test? (Endpoints)
- Medtech M&A starts off strong in 2026 (MedTech Dive)
- Quantum Surgical buys J&J’s NeuWave (MedTech Dive)
- Labcorp expands PathAI pact to roll out digital pathology platform in US (MedTech Dive)
- FDA posts early alert for safety issue with Impella heart pump devices (MedTech Dive)
- Candy and soda makers prepare to ‘play offense’ on SNAP restrictions (Food Dive)
- Analysis reveals scale of problems with school meals plan (Food Safety News)
- Trump administration pauses some Medicaid funding to Minnesota, citing fraud concerns (STAT)
- Judge rejects Kenvue bid to dismiss Texas lawsuit over Tylenol safety (Reuters)
- Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” and “Usual Course of Professional Practice” Regulations (FDA Law Blog)
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