Use of Expedited Approval Pathways Continues Upward Trend, FDA Study Shows
Use of FDA’s expedited approval pathways for new drugs increased from 42 percent in 2008 to more than 75 percent in 2021 — an increase that’s likely to continue as…
FDA Releases Draft Guidance on Assessing Growth, Puberty in Pediatric Trials
In a draft guidance released today, the FDA says trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact…
Alnylam Scraps Trial for Rare Eye Disease, Blames Inflation Reduction Act
Due to a provision in the recently passed Inflation Reduction Act (IRA), Alnylam Pharmaceuticals won’t be conducting a phase 3 trial of its RNAi therapeutic to treat the rare eye…
FDA Publishes Final Guidance for Small Entities Manufacturing HCT/Ps
The FDA clarifies its regulatory requirements for small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/P), in a final guidance released today. Source: Drug Industry…
FDA Once More Delays Action on Pompe Disease Candidate
The FDA has issued a Deferred Action letter for Amicus Therapeutics’ biologic license application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA, its investigational dual therapy for muscle-wasting Pompe…
FDA Rejects Gilead’s Hepatitis D Therapy Hepcludex
The FDA has declined to green-light Gilead Sciences’ hepatitis delta virus (HDV) drug bulevirtide because of manufacturing and delivery concerns, meaning there will continue to be no approved treatment for…
EMA Recommends Minimizing JAK Inhibitor Use for Some Patients
Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according…
FDA Denies Petition Seeking Withdrawal of Jazz’s Lung Cancer Drug Approval
The FDA has rejected a citizen petition pressing the agency to revoke the accelerated approval for Jazz Pharmaceuticals’ and PharmaMar’s Zepzelca (lurbinectedin), a treatment for adults with metastatic small cell lung…
FDA Panel Gives Unanimous ‘No’ to Y-mAbs Biologic for Pediatric Neuroblastoma
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 on Friday against recommending Y-mAbs Therapeutics’ biologic candidate for the treatment of central nervous system/leptomeningeal (CNS/LM) metastases in children with neuroblastoma…
GSK Gets a Partial Thumbs Up for Anemia Drug, Ends Plans for RA Drug
As the FDA’s decision date on GSK’s new drug application (NDA) for daprodustat — its chronic kidney disease anemia drug candidate — approaches, an FDA advisory panel said Wednesday that…
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