Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form…

Ongoing recalls of contaminated blood pressure drugs prompted the House Energy and Commerce Committee to call on Friday for a review of the FDA’s foreign drug inspection program. Source: Drug…

The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Source: Drug Industry Daily

In a big week for Pfizer, the world’s second largest drugmaker earned the FDA’s approval for a biosimilar cancer treatment and signed up the agency’s former Commissioner Scott Gottlieb for…

CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Source: Drug Industry Daily

The FDA released a proposed rule to codify the use of master files for biologics applications. Source: Drug Industry Daily

Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA…