Regulatory F FDA Law Blog
Regulatory news
Regulatory headlines from across biotech and life sciences, gathered from the industry press and linked straight to the publisher. Every story links straight to its publisher.
Regulatory
FDA Press Announcements
FDA Approves First Drug to Treat Alexander Disease
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
Regulatory
FDA Press Announcements
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
Regulatory
FDA Press Announcements
FDA Seeks Public Input to Advance Development of Botanical Drug Products
The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
Regulatory F FDA Law Blog
Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —
Regulatory
MHRA
MHRA and Manchester NHS partner on health innovation sandbox
New partnership to create health innovation sandbox that will test promising new technologies and build evidence to accelerate the safe adoption of technologies, including AI, in the NHS.
Regulatory
C&EN Pharmaceuticals
Business Watch: Solstice, Element cancel deal; FDA approves daraxonrasib for pancreatic cancer
Here’s what we’re watching in the chemical and pharmaceutical industries this week
Regulatory
Drug Delivery Business
MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance
MiniMed (Nasdaq: MMED) today reported Street-beating first-quarter revenue, upping its full-year sales guidance as it notched an early European regulatory win. The Northridge, California–based diabetes tech company, spun out of Medtronic earlier this year, announced a CE mark for…
Regulatory
EMA Press
Voluntary data submission pilot to advance innovative alternatives to animal testing
EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have…
Regulatory
MHRA
MHRA regulatory reform amendments tabled in Government’s Health Bill
Proposed amendments to support information sharing, regulatory reform and the future development of a medical device licensing regime.
Regulatory
MHRA
MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance
Avacopan Vifor is used in the treatment of some rare autoimmune diseases affecting small blood vessels.
Regulatory
MedCity News
First-in-Class Takeda, Protagonist Drug Lands FDA Approval in Rare Blood Disorder
Takeda Pharmaceutical’s Mimrylo is now approved for treating polycythemia vera, a rare blood cancer with limited therapeutic options. Originally developed by Protagonist Therapeutics, the engineered peptide gives Takeda a drug with blockbuster sales potential as the pharma compan…
Regulatory
FDA Press Announcements
FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
Regulatory
FDA Press Announcements
FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
Regulatory
FDA Press Announcements
FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
Regulatory
Drug Delivery Business
Abbott wins FDA authorization for dual glucose-ketone sensor
Abbott (NYSE:ABT) announced today that the FDA has authorized its dual glucose-ketone sensing technology for people with diabetes. The authorization of the Libre Duo 10 Day system — which provides 10 days of wear time — comes three months after the company reported a CE mark in t…
Regulatory
Drug Discovery and Development
FDA greenlights ViiV’s Tivicay PD for HIV-positive newborns in first month of life
The FDA has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for treating HIV-1 in pediatric patients weighing at least 2 kg, including eligible newborns, the company and FDA announced. FDA first approved Tivicay in August 2013 for adults and adolescents aged 12 or older weig…
Regulatory
FDA Press Announcements
FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
Regulatory
FDA Press Announcements
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.
Regulatory
Drug Discovery and Development
FDA logs more than 1,700 adverse event reports involving compounded semaglutide and tirzepatide
In April, The New York Times proclaimed that a gen-AI-driven company that hawked compounded GLP-1 drugs was potentially on track to have $1.8 billion in 2026 sales. The paper also reported that the company, MEDVi, had generated $401 million in sales in 2025, saying it had been gi…
Regulatory
Drug Delivery Business
FDA clears Roche’s Alzheimer’s blood test for rule-in and rule-out assessment
Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that the FDA has cleared its Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test that identifies amyloid pathology associated with Alzheimer’s disease. The test is cleared for people 55 and older…
Regulatory
MHRA
MHRA advises against using rectal catheters sold for personal use in infants
MHRA advises parents and carers against using rectal catheters sold for personal use (known as gas and colic relievers) in babies.
Regulatory
FDA Press Announcements
FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa)
Regulatory
C&EN Pharmaceuticals
Drug industry leaders size up Trump’s FDA commissioner nominee
White House aide Heidi Overton has been tapped to lead the agency after a tumultuous period
Regulatory
FDA Press Announcements
FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
Regulatory
Drug Discovery and Development
FDA issues final PDUFA meeting guidance, expands use of written responses
The FDA has finalized new guidelines for meetings between the FDA and sponsors or applicants relating to the development and review of drugs or biological products under the Prescription Drug User Fee Act (PDUFA). The FDA first published…
Regulatory
MHRA
MHRA sets out position on regulation of microbiome-based medicinal products
MHRA publishes position paper clarifying the UK licencing route for microbiome-based medicines, supporting developers to bring these innovative therapies to patients.
Regulatory
MHRA
Vimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours
As with any medicine, the MHRA will keep the safety and effectiveness of vimseltinib (romvizma) under close review.
Regulatory
MHRA
MHRA reaffirms the safety of childhood vaccination
Vaccination is one of the most effective and safest ways to protect against many serious infectious diseases
Regulatory
C&EN Pharmaceuticals
FDA approves first oral PCSK9 inhibitor for managing cholesterol
Merck & Co.'s macrocyclic peptide enlicitide to be marketed as Lipfendra