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The FDA provides clarity for drugmakers in a final guidance on how the agency’s considerations about a drug’s risks and benefits factor into NDA and BLA premarket and postmarket decisions. Read More
The FDA handed out a fistful of approvals this week, including three for Merck’s juggernaut PD-1 blocker Keytruda, bringing the drug’s total indications to 36. Read More
CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered for more than one PET scan per lifetime, and need not be in a clinical trial to receive the scan. Read More
The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs. Read More
Alvotech announced Thursday that the FDA has issued a complete response letter (CRL) for the company’s BLA for AVT04, a biosimilar candidate to Stelara (ustekinumab), for deficiencies found during a March FDA inspection of its manufacturing facility. Read More
The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Read More
Alnylam Pharmaceuticals today announced that the FDA has issued a complete response letter (CRL) on its supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis and will no longer pursue the expanded indication. Read More
Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy docetaxel, according to the Oncologic Drugs Advisory Committee (ODAC), which met Thursday. Read More
US WorldMeds got a 14-6 thumbs-up from FDA’s Oncologic Drugs Advisory Committee, supporting DFMO (difluoromethylornithine) to reduce the risk of relapse in children in remission after multifaceted treatment for high-risk neuroblastoma. Read More