Pazdur Fda - QuikReader

Richard Pazdur, FDA Cancer Chief, Discusses 25 Years of Innovation

Dr. Richard Pazdur for 25 years has overseen innovations in the treatment of deadly diseases at the agency.

Health - The New York Times - 34 minutes ago

FDA Names a New Chief of Medical Devices

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

Business - The New York Times - October 22

Compounding pharmacies can resume making tirzepatide as FDA reconsiders shortage

The FDA said in a court filing late Friday that it would allow pharmacists to continue making compounded versions of tirzepatide as it reconsiders whether the drug is in shortage.

FDA will reconsider decision barring copycat versions of Lilly weight loss drug

The Food and Drug Administration (FDA) said it will reconsider its decision to remove Eli Lilly’s blockbuster weight loss and diabetes drug from its official shortage list and allow compounding ...

Politics - The Hill - October 14

FDA Freezes COVID-Flu Combo Vaccine Trial Over Safety Concern

Maker Novavax reported a recipient of the combination vaccine experienced symptoms of nerve cell damage.

Business - Inc. - October 16

AbbVie wins FDA nod for infusion treatment for advanced Parkinson’s disease

Vyalev is the first subcutaneous 24-hour continuous infusion of levodopa-based therapy for advanced Parkinson’s disease.

Business - MarketWatch - October 17

FDA recalls thousands of antidepressant bottles due to cancer-causing chemical

The Food and Drug Administration (FDA) issued a Class II recall of more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a carcinogen. Duloxetine belongs to a ...

Politics - The Hill - October 23

FDA identifies possible sources of McDonald's E. coli outbreak

The FDA is looking into two possibilities as the source of an E. coli outbreak linked to McDonald's Quarter Pounder burgers. CBS News Colorado reporter Karen Morfitt has the latest.

FDA eyes McDonald's supplier's onions as source of E. Coli outbreak

The FDA said Thursday that it's investigating whether McDonald’s supplier Taylor Farms is the possible source of the E. coli outbreak linked to Quarter Pounders hamburgers.

FDA investigates onion supplier in McDonald's E. coli outbreak

The FDA says it is focusing on a California company that sells McDonald's and other restaurants onions. McDonald's says California-based Taylor Farms is the source of the potentially tainted onions ...

FDA investigating if onions are source of E. coli outbreak linked to McDonald's

McDonald's on Thursday confirmed to CBS News that California-based produce giant Taylor Farms is the supplier of slivered onions that have been removed from many of its restaurants amid an E. coli ...

Orange, Black and Red Dye No.3: Halloween lessons for the FDA

As America’s children prepare for their annual candy shakedown of America’s grown-ups, it’s time for regulators to get on the (broom)stick and fly in with an important public health intervention.

Politics - The Hill - October 31

RFK Jr. says 'entire departments' at FDA 'have to go'

Former presidential candidate Robert F. Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are "entire departments" within the Food and ...

Politics - The Hill - 2 days ago

FDA proposes ending use of decongestant found in many cold, allergy medicines

The FDA said the proposed order is not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now.

Business - CNBC - Yesterday

FDA to pull common but ineffective cold medicine from market

The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal decongestant."

FDA proposes removing ineffective decongestant found in most cold medicine

The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work. The move brings FDA ...

Politics - The Hill - Yesterday

FDA proposes ending use of decongestant found in many cold, allergy medicines

The FDA has proposed ending the use of an ingredient in many over-the-counter cold and allergy medications because it doesn’t actually relieve nasal congestion.

Maine shooting survivors claim Army negligence and FDA's weight-loss drug decision: Morning Rundown

Detroit, TCF Center, 2024 election, Harris in Pennsylvania, Lewiston Maine shooting, Trump rally shooting survivors, giant pandas at National Zoo, Mount Everest

Novavax’s stock slides 19% after FDA puts clinical hold on COVID and flu vaccine candidates

Novavax Inc.’s stock tumbled 19% early Wednesday after the company said the FDA has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a ...

Business - MarketWatch - October 17

Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge

The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial.

Business - CNBC - October 16

Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies

The Danish drugmaker Novo Nordisk argues that semaglutide, the active ingredient in Ozempic and Wegovy, are too complex for those manufacturers to make safely.

Business - CNBC - October 23

Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copycats

Novo Nordisk wants the Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own versions of the company’s popular weight loss drug Wegovy and diabetes ...

Politics - The Hill - October 23

Novo Nordisk's Ozempic and Wegovy now available in the U.S. after shortages, FDA says

It is a sign that Novo Nordisk's efforts to ramp up the supply of those drugs are starting to pay off, as demand continues to skyrocket in the U.S.

Business - CNBC - October 30

Latest in Pazdur Fda

Richard Pazdur, FDA Cancer Chief, Discusses 25 Years of Innovation

FDA Names a New Chief of Medical Devices

Compounding pharmacies can resume making tirzepatide as FDA reconsiders shortage

FDA will reconsider decision barring copycat versions of Lilly weight loss drug

FDA Freezes COVID-Flu Combo Vaccine Trial Over Safety Concern

AbbVie wins FDA nod for infusion treatment for advanced Parkinson’s disease

FDA recalls thousands of antidepressant bottles due to cancer-causing chemical

FDA identifies possible sources of McDonald's E. coli outbreak

FDA eyes McDonald's supplier's onions as source of E. Coli outbreak

FDA investigates onion supplier in McDonald's E. coli outbreak

FDA investigating if onions are source of E. coli outbreak linked to McDonald's

Orange, Black and Red Dye No.3: Halloween lessons for the FDA

RFK Jr. says 'entire departments' at FDA 'have to go'

FDA proposes ending use of decongestant found in many cold, allergy medicines

FDA to pull common but ineffective cold medicine from market

FDA proposes removing ineffective decongestant found in most cold medicine

FDA proposes ending use of decongestant found in many cold, allergy medicines

Maine shooting survivors claim Army negligence and FDA's weight-loss drug decision: Morning Rundown

Novavax’s stock slides 19% after FDA puts clinical hold on COVID and flu vaccine candidates

Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge

Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies

Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copycats

Novo Nordisk's Ozempic and Wegovy now available in the U.S. after shortages, FDA says

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