Los Angeles-based biopharmaceutical firm Enochian BioSciences received a green light from the U.S. Food and Drug Administration for feedback on a possible cure for infections caused by the hepatitis B virus (HBV).
The U.S. Food and Drug Administration on July 9 called for an independent federal probe into its representatives’ interactions with Biogen Inc. that led to approval of the company’s Alzheimer’s disease drug during June 2021.
The U.S. Food and Drug Administration granted Seagen Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) regular approval in the United States, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Pfizer and partner BioNTech plan to ask U.S. and European regulators within weeks to authorize a booster dose of the companies’ Covid-19 vaccine, based on evidence of greater risk of infection six months after inoculation and the spread of the highly contagious Delta variant.
Biogen Inc. on July 8 said the U.S. Food and Drug Administration narrowed use of the company’s Alzheimer’s drug after the regulatory agency drew sharp criticism for its broad approval of the drug in June 2021 without proof of clear benefit against the disease.
Drugmakers AstraZeneca and Amgen said on July 8 their experimental drug tezepelumab was granted a speedy review by the U.S. Food and Drug Administration for potential approval as a treatment for asthma.
Valneva SE was awarded Breakthrough Therapy Designation for the company’s single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration.
After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
Novartis will manufacture the anti-cholesterol medicine Leqvio at the company’s own plant in Austria to supply the United States as the Swiss drugmaker seeks U.S. approval that has been delayed by regulatory concerns over a contractor’s Italian facility.
The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent
