FDA

FDA panel to review psychedelic drug MDMA for first time
Reuters
Tue, 06/4/24 - 11:40 am
FDA
MDMA
PTSD
psychedelic drugs
Lykos Therapeutics
FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
Reuters
Sun, 06/2/24 - 02:50 pm
Moderna Therapeutics
FDA
RSV
vaccines
Dupixent nears EU approval for COPD, as FDA delays
Pharmaphorum
Fri, 05/31/24 - 10:49 am
Sanofi
Regeneron
Dupixent
COPD
EMA
Europe
FDA
Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma
Fierce Pharma
Thu, 05/30/24 - 11:10 pm
Bristol Myers Squibb
Breyanzi
FDA
mantle cell lymphoma
FDA grants IND clearance for Spinogenix’s ALS treatment trial
Clinical Trials Arena
Thu, 05/30/24 - 11:13 am
Spinogenix
ALS
clinical trials
SPG302
FDA
FDA Approves Selpercatinib for Pediatric Patients With RET-Altered Metastatic Thyroid Cancer, Solid Tumors
Oncology Nursing News
Wed, 05/29/24 - 09:41 pm
Eli Lilly
FDA
Retevmo
pediatrics
thyroid cancer
Tris Pharma captures FDA nod for non-stimulant ADHD treatment Onyda XR
Fierce Pharma
Wed, 05/29/24 - 09:36 pm
Tris Pharma
ADHD
Onyda XR
FDA
Psychoactive drugs are having a moment. The FDA will soon weigh in.
Medical Marketing and Media
Wed, 05/29/24 - 11:23 am
FDA
psychoactive drugs
MDMA
FDA advisers back approval for Guardant's blood-based cancer test
Reuters
Thu, 05/23/24 - 09:40 pm
Medtech
Guardant Health
FDA
colorectal cancer
diagnostics
FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin
Reuters
Wed, 05/22/24 - 11:35 am
Novo Nordisk
diabetes
FDA
insulin
hypoglycemia
FDA Updates PDUFA Date of BLA for Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors
Onc Live
Tue, 05/21/24 - 07:15 pm
FDA
Bristol Myers Squibb
Opdivo
Halozyme
solid tumors
FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters
Tue, 05/21/24 - 11:12 am
diagnostics
Medtech
Guardant Health
colorectal cancer
FDA
FDA competition seeks digital endpoints for Parkinson’s
Pharmaphorum
Tue, 05/21/24 - 11:01 am
FDA
digital health
Parkinson's Disease
FDA approves two biosimilars to blockbuster eye drug Eylea
Reuters
Mon, 05/20/24 - 11:23 am
Regeneron
Eylea
FDA
biosimilars
Biocon Biologics
Yesafli
Opuviz
Samsung BioLogics
Biogen
FDA clears Neuralink's brain chip implant in second patient, WSJ reports
Reuters
Mon, 05/20/24 - 11:06 am
Neuralink
Medtech
FDA
brain implants
Elon Musk
BD wins FDA approval for cervical cancer screening self-collection kit
Medtech Dive
Fri, 05/17/24 - 11:09 am
BD Medical
Medtech
diagnostics
FDA
HPV
cervical cancer
Lung disease imaging AI from Brainomix gets FDA nod
Pharmaphorum
Fri, 05/17/24 - 11:07 am
Medtech
Brainomix
artificial intelligence
e-Lung
FDA
imaging
interstitial lung disease
FDA approves Amgen drug for small cell lung cancer
Reuters
Thu, 05/16/24 - 09:47 pm
Amgen
tarlatamab
FDA
small cell lung cancer
FDA clears IND for Verismo Therapeutics’ CAR-T therapy
Clinical Trials Arena
Wed, 05/15/24 - 11:29 am
Verismo Therapeutics
CAR-T SynKIR-310
FDA
clinical trials
relapsed or refractory B cell lymphoma
Another delay for Ascendis' hormone therapy as FDA extends review by 3 months
Fierce Pharma
Tue, 05/14/24 - 11:06 pm
Ascendis Pharma
Transcon PTH
FDA
hypoparathyroidism

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