In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone…

Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce…

Scottsdale, Ariz.-based BioLab Sciences has received an FDA warning letter for selling human tissue products without approved Biologics License Applications and for persistent deviations from current good manufacturing practice (cGMP)…

Spectrum Pharmaceutical’s experimental cancer drug Pozenveo (poziotinib) got the thumbs down from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a vote of nine to four yesterday. Source: Drug Industry…

The FDA’s Vaccines and Related Biological Products Advisory Committee agreed yesterday — somewhat grudgingly — that Rebyota (RBX2660), Rebiotix’s standardized fecal microbiota suspension, is a safe and effective treatment for…

In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory…

In many ways, there are more questions than answers in the FDA’s long-awaited and recently published Overdose Prevention Framework. Source: Drug Industry Daily

Following a month-long inspection in August, the FDA reprimanded Catalent for numerous quality lapses observed at its Bloomington, Ind., plant — where the drugmaker has performed manufacturing activities for both…

Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for…

Merck has found a way forward for its stalled oral antiretroviral islatravir, using a lower, 0.75 mg dose in three newly launched phase 3 trials and in a previously paused…