Safety

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, adding a black box warning about liver injury along with suggested liver and cardiac monitoring.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, limiting treatment to ambulatory Duchenne muscular dystrophy patients.

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

The company’s third quarter earnings fell by $67.8m year-over-year, reflecting the tumultuous situation around its DMD therapy Elevidys in June.

In addition to Kenvue, complaint names as defendant J&J, which for decades marketed Tylenol oral analgesics before spinning Kenvue out in 2023. State asks court to order firms to pay $10,000 for each violation of state Deceptive Trade Practices-Consumer Protection Act.

The company reported that a patient went to the emergency room after experiencing grade 4 transaminase elevations, which unlike a similar event in May caused symptoms.

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

US firm’s first-to-market approval gives Endo a foothold in the rare metabolic disease space, widening access to a life-saving therapy for patients with urea cycle disorders.

In an at times incendiary letter, Republican senators have urged the FDA and HHS to suspend approval of a new generic version of the abortion pill mifepristone, citing safety concerns and ongoing federal reviews.

FDA rejects NPAs arguments for clarity on when it recognizes start of investigational new drug programs and what constitutes “substantial clinical investigations” for an IND. Clock starts after FDA met twice-extended deadline to provide answers to NPA’s questions in a 2023 petition.

Among critics of Trump administration's moves, American Academy of Pediatrics says “White House event on autism was filled with dangerous claims and misleading information.”

“I knew when I was pregnant with my kids the first thing, I knew from just talking to my other friends, before you take anything when you're pregnant, you go to talk to your doctor. I think that's what most pregnant women do,” says regulatory attorney Christine Lawson.