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A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER. Read More
GlaxoSmithKline is buying Sierra Oncology and its investigational cancer drug momelotinib in a $1.9 billion windfall for the San Mateo, Calif.- based biopharmaceutical company. Read More
Two online pharmacies selling stimulant drugs were hit with warning letters from the FDA for unlawfully offering to distribute or dispense stimulants that are Schedule II controlled substances, including amphetamine drug products. Read More
The FDA has cited Clearfield, Utah-based Yusef Manufacturing Laboratories for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and deemed the company’s products adulterated. Read More
A $2.1 million gene therapy with the potential to cure beta-thalassemia, a lifelong blood disorder, is worth the price, according to the Institute for Clinical and Economic Review (ICER). Read More
The company is working with regulators in the U.S., Europe and the UK to find ways to gain approval for this drug for the treatment of COVID-19. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has rapped Bausch Health for making false and misleading claims for its topical psoriasis treatment Duobrii. Read More
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease. Read More