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US FDA pauses Novavax's trial of combo COVID-flu shot

MarketWatch · 3h

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

Novavax Inc.’s stock tumbled 16% 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 case of motor neuropathy in a participant in a mid-stage trial.

US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns

The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on hold after one person who received the shot reported nerve damage, the company said on Wednesday.

Hosted on MSN · 22h

Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines

The vaccine maker said the regulator placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S.

Novocure, FDA and Optune Lua

Investing.com on MSN · 1d

Novocure shares soar 33% as FDA approves lung cancer treatment

Novocure Ltd (NASDAQ:NVCR) shares soared sharply after the announcement that the FDA had approved Optune Lua, a wearable device designed to treat certain types of lung cancer. The stock surged more than 33% in premarket

MarketWatch · 1d

Novocure Shares Rise After FDA Approves Optune Lua Cancer Treatment

Shares of Novocure were trading higher in Tuesday's late session after the company said that the Food and Drug Administration had approved Optune Lua, its wearable treatment for certain types of lung cancer.

Business Insider · 16h

NovoCure’s Optune Lua Gains FDA Approval for NSCLC, Projecting Significant Sales Growth and Expansion

H.C. Wainwright analyst Emily Bodnar upgraded the rating on NovoCure (NVCR – Research Report) to a Buy today, setting a price target of

1hOpinion

Commentary: FDA’s lack of vape enforcement is hurting small businesses

Thanks to the leadership of Gov. Ron DeSantis, Attorney General Ashley Moody and the Florida Legislature, a new state law to ...

For this cancer-focused digital health startup, an FDA rejection meant the end of the road

Blue Note’s failure to clear the FDA hurdle offers a rare window into the regulatory challenges faced by digital therapeutics ...

1d

FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now

TUESDAY, Oct. 15, 2024 (HealthDay News) -- Pharmacists may continue making compounded versions of the weight-loss medication ...

News Medical on MSN7h

FDA strengthens AI regulation to ensure patient safety and innovation in healthcare

The FDA is adapting regulations to manage AI’s rapid development in healthcare, focusing on patient safety and the life cycle ...

The biggest challenge facing the FDA’s new Rare Disease Innovation Hub

Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting ...

FDA-Cleared Medical Devices Lack Proper Vetting, Doctors Say

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the ...

22hon MSN

US FDA pauses Novavax's trial of combo flu-COVID shot on safety concerns

The U.S. Food and Drug Administration has placed a hold on trials of Novavax's COVID and influenza combination vaccine, as ...

Ahead of public meeting, FDA signals flexibility in evaluating smoking cessation treatments

FDA leaders said the agency was willing to consider broader endpoints in clinical trials of smoking cessation products ...

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