FDA

All articles by FDA

FDA adcomm recommends Alzheimer’s drug Leqembi for full approval
FDA adcomm recommends Alzheimer’s drug Leqembi for full approval
Jack O'Brien
June 9, 2023
4:26 pm

Looking forward, the FDA’s Prescription Drug User Fee Act date for Leqembi is July 6.

FDA’s workforce goals: tackling recruitment, retention and burnout
FDA’s workforce goals: tackling recruitment, retention and burnout
Lecia Bushak
June 5, 2023
4:20 pm

As the FDA transitions out of COVID-19 crisis mode, its chief of staff Julie Tierney says the agency is looking to ramp up its hiring and retention efforts.

FDA warns about unauthorized versions of Ozempic and Wegovy amid shortage
FDA warns about unauthorized versions of Ozempic and Wegovy amid shortage
Lecia Bushak
June 1, 2023
2:38 pm

As Novo Nordisk struggles to meet the demand for its diabetes drugs Ozempic and Wegovy, some compounded pharmacies are creating unauthorized versions.

Pfizer joins GSK with FDA greenlight for RSV vaccine
Pfizer joins GSK with FDA greenlight for RSV vaccine
Jack O'Brien
June 1, 2023
11:10 am

Pending results of a CDC adcomm meeting, Pfizer said it anticipates vaccine supply availability in Q3 2023 ahead of the start of the 2023/24 RSV season this fall.

Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
Jack O'Brien
May 26, 2023
11:00 am

Neuralink said that clinical trial recruitment is not yet open but added that it would announce more information in the future.

GSK nabs first FDA approval for RSV vaccine
GSK nabs first FDA approval for RSV vaccine
Jack O'Brien
May 3, 2023
2:00 pm

In light of the approval, GSK said it intends to launch Arexy prior to the start of the 2023/24 RSV season this fall.

FDA approves Biogen and Ionis’ Tofersen for rare genetic form of ALS
FDA approves Biogen and Ionis’ Tofersen for rare genetic form of ALS
Jack O'Brien
April 25, 2023
3:55 pm

The FDA’s decision came just over a month after an advisory committee issued a mixed vote on Tofersen.

Supreme Court keeps abortion drug mifepristone on the market, for now
Supreme Court keeps abortion drug mifepristone on the market, for now
Jack O'Brien
April 21, 2023
7:28 pm

The procedural ruling granted the temporary stays requested by the federal government and keeps mifepristone available while the lawsuits proceed in the lower courts. 

After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
Irena Hwang, ProPublica
April 20, 2023
11:30 am

In the wake of recent deaths from bacteria-tainted eyedrops, a ProPublica analysis of FDA data reveals that the agency inspected only 6% of the overseas plants where drugs and their ingredients are produced in 2022.

FDA rebuffs Eli Lilly’s ulcerative colitis drug mirikizumab over manufacturing concerns
FDA rebuffs Eli Lilly’s ulcerative colitis drug mirikizumab over manufacturing concerns
Jack O'Brien
April 14, 2023
10:04 am

The FDA’s rejection also comes nearly one year after Lilly released promising data from a Phase 3 trial for mirikizumab.

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