Regulatory Authority Actions

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

The agency will be reorganizing field force and compliance functions.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Leaders at CDER and CBER give update on organizational changes at FDA.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

As more novel therapy approvals trend towards biologics, it is important to take stock of what treatments are shaping the future of the market.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

The updated vaccine will be ready to ship following a positive European Commission review.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.