FDAnews Drug Daily Bulletin

The FDA is projecting a sluggish start for its new biosimilars approval pathway.

An informal working group of the International Conference on Harmonisation (ICH) is looking into revising or rewriting the “dated” Q7 standard on GMPs for active pharmaceutical ingredients (API), an FDA official says.

DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter.

The FDA has approved the positron emission tomography (PET) imaging agent Choline C 11 Injection for production and use in detecting recurrent prostate cancer.

As the U.S. wrestles with its biggest whooping cough outbreak in decades, researchers appear to have zeroed in on the main cause: The safer vaccine that was introduced in the 1990s loses effectiveness much faster than previously thought.

Do you have a headache? Stomach ache? Back pain? For many people, the first impulse when they feel pain is to reach for the bottle of Tylenol or their OTC painkiller of choice.

Oncolytics Biotech said it expanded enrollment in a late-stage study testing its head and neck cancer drug to determine its effects on two distinct patient groups.

Medical company Ethicon will spend $185 million to add a 100,000-square-foot facility in Athens, Ga., creating 75 jobs through 2016.

Pfizer’s joint venture with Zhejiang Hisun Pharmaceutical plans to hire 600 people in China by the end of the year, its CEO said.