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Pfizer announced Tuesday that its bivalent respiratory syncytial virus (RSV) vaccine candidate met one of two primary endpoints when administered to pregnant participants to help protect their infants from RSV disease after birth. Read More
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 innovative biologic therapies targeting rare diseases seek marketing approval, according to a team of senior FDA officials that recommends the agency exercise caution in speeding new drug approvals. Read More
The EMA panel recommended that JAK inhibitors be used cautiously, if at all, in patients who are age 65 years and older, at increased risk of major cardiovascular problems, past and current smokers or those with a history of cancer. Read More
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. Read More
In a draft guidance released today, the FDA says trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential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 on participants’ physical growth and sexual development. Read More
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 condition Stargardt disease. Read More
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 disease. Read More