Desk

Approvals & regulatory

FDA and EMA decisions, advisory committees, labels and rejections.

Approvals & regulatory · 5h ago

XtalPi Submits U.S. FDA IND Application for KQTD-126, a Potential First-in-Class, Gut-Restricted Pan-TRK Inhibitor for Chronic Intestinal Pain

1 outlet FDA

Approvals & regulatory · 11h ago

FDA adcomm votes in favor of benefit-risk of Grail’s cancer test

4 outlets FDA

Approvals & regulatory · 9h ago

STAT+: Heidi Overton, Trump’s pick for FDA head, to face questions at Senate hearing

2 outlets FDA

Approvals & regulatory · 12h ago

U.S. Food and Drug Administration (FDA) approves Lilly's Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes

4 outlets Eli Lilly FDA

Approvals & regulatory · 8h ago

FDA Nominee Voices Support for Vaccines at Senate Hearing Scrutinizing Trump's Moves

1 outlet Vaccines & mRNA FDA

Approvals & regulatory · 13h ago

FGFR2 inhibitor Lyrfigtu wins FDA approval for bile duct cancer

3 outlets FDA

Approvals & regulatory · 11h ago

Altruist Biologics preps for production following EMA GMP certification

2 outlets EMA

Approvals & regulatory · 9h ago

Grail multicancer detection test wins FDA advisers’ backing

1 outlet FDA

Approvals & regulatory · 9h ago

FDA Approves New Option for Previously Treated Bile Duct Cancer

1 outlet FDA

Approvals & regulatory · 12h ago

Senators grill FDA nominee Heidi Overton

2 outlets FDA

Approvals & regulatory · 9h ago

Where does FDA nominee Overton stand on vaccines and other key pharma issues?

1 outlet Vaccines & mRNA FDA

Approvals & regulatory · 9h ago

Merck Welireg, Eisai Lenvima combo approved for kidney cancer

1 outlet Merck & Co. (MSD)

Approvals & regulatory · 10h ago

STAT+: FDA commissioner nominee Heidi Overton keeps opinions to herself in Senate hearing

1 outlet Vaccines & mRNA FDA

Approvals & regulatory · 10h ago

FDA commissioner nominee Overton rebuffs questions about Trump medical claims

1 outlet FDA

Approvals & regulatory · 10h ago

The FDA’s Overton era, and dispatches from Shanghai

1 outlet FDA

Approvals & regulatory · 11h ago

FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’

1 outlet GLP-1 & obesity drugs Eli Lilly FDA

Approvals & regulatory · 14h ago

Eli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry

2 outlets Eli Lilly FDA

Approvals & regulatory · 14h ago

GRAIL's Galleri test wins endorsement from FDA panel

2 outlets FDA

Approvals & regulatory · 15h ago

AstraZeneca granted EU label expansion for COPD therapy, Trixeo in asthma

2 outlets AstraZeneca

Approvals & regulatory · 14h ago

Regulatory: FDA nods for Intrabio, Nuvation, Fempulse, Xenix and more

1 outlet Eli Lilly AstraZeneca

Approvals & regulatory · 14h ago

Awiqli insulin, this time for Lilly, with FDA-cleared Onswik

1 outlet Eli Lilly FDA

Approvals & regulatory · 14h ago

GRAIL sets new 52-week high as FDA panel backs cancer test

1 outlet FDA

Approvals & regulatory · 14h ago

Marani Health Receives FDA Clearance for M•care System, Clearing the Path Toward Commercial Launch

1 outlet FDA

Approvals & regulatory · 14h ago

FDA Panel Narrowly Backs Multi-Cancer Blood Test Despite Doubts It Works

1 outlet FDA

Approvals & regulatory · 16h ago

Trump's FDA pick Heidi Overton calls vaccines, mifepristone safe and effective in confirmation hearing

1 outlet Vaccines & mRNA FDA

Approvals & regulatory · 16h ago

Eli Lilly outlays $3.35bn for secretive drug discovery pact with China’s InnoCare

1 outlet Eli Lilly

Approvals & regulatory · 16h ago

Merck’s experimental eye drug matches Roche’s VEGF inhibitor but safety concerns emerge

1 outlet Merck & Co. (MSD) Roche

Approvals & regulatory · 17h ago

Kyverna steps closer to FDA-first CAR T for an autoimmune condition with durability data

1 outlet CAR-T & cell therapy FDA

Approvals & regulatory · 17h ago

STAT+: Pharmalittle: We’re reading about the FDA commissioner nominee, a Lilly partnership in China, and more

1 outlet Eli Lilly FDA

Approvals & regulatory · 17h ago

Lilly's rival to Novo's new Awiqli insulin gets FDA approval

1 outlet Eli Lilly Novo Nordisk

Approvals & regulatory · 17h ago

Glytec Receives FDA Breakthrough Device Designation for Glucommander Pediatrics, an Insulin Management Technology for Hospitalized Newborns and Infants

1 outlet FDA

Approvals & regulatory · 17h ago

Peer-Reviewed Study Published in Spine Open Demonstrates Superior Two-Year Clinical Outcomes for FDA-Approved Synergy Disc® Compared with Cervical Fusion

1 outlet FDA

Approvals & regulatory · 17h ago

FDA Advisors Recommend Galleri Multicancer Blood Test

1 outlet FDA

Approvals & regulatory · 17h ago

WuXi Biologics Passes Another FDA GMP Inspection, Reinforcing Its Quality Track Record and Commercial Supply Reliability

1 outlet FDA

Approvals & regulatory · 17h ago

Mesoblast wins FDA nod for new potency assay for Ryoncil

1 outlet FDA

Approvals & regulatory · 19h ago

Lilly wins FDA nod for once-weekly insulin product, Onswik

1 outlet Eli Lilly FDA

Approvals & regulatory · 20h ago

Kyverna says long-term data bolster FDA submission for rare autoimmune CAR-T

1 outlet CAR-T & cell therapy FDA

Approvals & regulatory · 21h ago

STAT+: How a young doctor rose from rural New Mexico to FDA commissioner nominee

1 outlet FDA

Approvals & regulatory · 22h ago

EC approves first triple-combination therapy for asthma maintenance

1 outlet AstraZeneca

Approvals & regulatory · yesterday

Grail’s Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval

1 outlet FDA

Approvals & regulatory · yesterday

STAT+: Nominee to lead FDA aims to speed up medical research, combat China’s rise

1 outlet FDA

Approvals & regulatory · yesterday

STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks

1 outlet FDA

Approvals & regulatory · yesterday

FDA Warns Pharmacy About Illegal GLP-1 Compounding

1 outlet GLP-1 & obesity drugs FDA

Approvals & regulatory · yesterday

Thank you Analysis Life Sciences FDA launches expedited IND pilot, fills in details on its design

1 outlet FDA

Approvals & regulatory · yesterday

Roche-Ionis’ RNA therapy reduces kidney disease marker, opening path to swift FDA nod

2 outlets Roche FDA