Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Glaxo’s Jesduvroq as Oral Treatment for Anemia ( Reuters ) ( Endpoints ) COVID-19 tracker: Merck pill linked to new mutations, study says ( Fierce ) ( Bloomberg ) FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test ( Inside Health Policy ) ( Endpoints ) What Changes When the COVID Emergency Ends in May? ( MedPage Today ) Modern...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. to end COVID-19 emergency declarations on May 11 ( Reuters ) ( Bloomberg ) ( STAT ) As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions ( Pink Sheet ) FDA Launches Plans for Food Program Revamp After Watchdog Review ( Bloomberg ) End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timefr...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting ( Endpoints ) ( FDA ) ( MedPage Today ) Lilly Gets U.S. FDA Approval of Jaypirca to Treat MCL ( Bloomberg ) ( BioSpace ) ( Endpoints ) FDA approves Italy-based pharma's oral SERD for some breast cancer patients ( Endpoints ) ( Fierce ) Drugmakers prevail in dispute over U.S. ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA joins global regulators probing tainted overseas cough syrup ( Reuters ) ( CBS News ) AstraZeneca’s Covid Drug No Longer Authorized for Use in the US ( Bloomberg ) ( STAT ) Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines ( STAT ) Inhibikase, FDA find common ground to lift hold on Parkinson’s drug ( Fierce ) Updated COVID v...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Many pediatric drug study results were never posted to a U.S. government database ( STAT ) COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel ( Pink Sheet ) US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible ( Pink Sheet ) Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rar...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA scientists propose an annual Covid shot matched to current strains ( STAT ) ( Reuters ) With TheracosBio green light, another SGLT2 wades into diabetes arena ( Fierce ) Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal ( Pink Sheet ) FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA argues public harm if court reverses abortion pill approval ( The Hill ) ( Endpoints ) ( Bloomberg ) ( Fierce ) Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs ( Endpoints ) ( Fierce ) Diversity in Clinical Trials as FDA Gets a Boost From New Law ( Bloomberg ) FDA’s Novel Approvals Again Led By Oncology And Neurology, But D...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Entering J&J’s fiefdom, Luye wins FDA approval of long-acting schizophrenia drug ( Fierce ) ( Pharmaphorum ) Reversing abortion drug's approval would harm public interest, U.S. FDA says ( Reuters ) Orphan Drug Exclusivity Remains a Priority in 2023, Says FDA Deputy Commissioner ( FDAnews ) FDA’s Biosimilar Regulatory Science Pilot Launches With Five Projects (...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Bivalent Shot Shot Linked to Stroke in One Safety Database ( Bloomberg ) ( MMWR ) ( Reuters ) Novo Nordisk's GLP-1 for Type II diabetes approved for first-line treatment ( Endpoints ) ( Biospace ) AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales ( Fierce ) David Kessler, Biden official key to covid vaccine effort, steps down...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Novel Dual Rescue Inhaler for Asthma in Adults ( MedPage Today ) FDA rejects Biocon insulin biosimilar over data, manufacturing concerns ( Fierce ) JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response ( Fierce ) Physicians group urges FDA to convene expert panel before finally approving an ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. experts recommend weight-loss drugs for obese children ( Reuters ) Abbvie raises sales outlook of two immunology drugs to more than $17.5 bln in 2025 ( Reuters ) Sen. Sanders asks Moderna not to hike COVID vaccine price ( Reuters ) ( STAT ) FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises” ( STAT ) FDA Increasingly Halting Hum...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Supreme Court rebuffs Pfizer plan to help patients pay for heart medication ( Reuters ) ( Bloomberg ) FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate ( Endpoints ) Lundbeck and Otsuka win FDA priority review of Alzheimer’s agitation drug ( Medwatch ) Doctors inclined to prescribe new Alzheimer’s drug despite conce...