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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

The Boston Globe · 7h

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old man who received a similar product in a clinical trial for a different form of muscular dystrophy.

Bloomberg on MSN · 6h

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.

FDA Authorizes Juul’s E-Cigarettes

Politico · 14h

FDA makes Juul’s reign official

JUUL GETS ITS CROWN — The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining they’re “appropriate for the protection of public health” because their benefits to adult smokers of combustible cigarettes outweigh the risks to nonsmoking youths.

Associated Press News on MSN · 1d

Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes

Federal health officials will allow Juul to keep selling its electronic cigarettes. The Food and Drug Administration said Thursday that Juul's benefits as a less harmful alternative for adult smokers outweigh the risks of teen use.

The Wall Street Journal on MSN · 1d

FDA Authorizes Juul’s E-Cigarettes After Ban Nearly Bankrupted Firm

The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to the brink of bankruptcy.

GSK, FDA and Cancer Drug

Reuters · 1d

GSK's blood cancer drug fails to secure US FDA advisers' support

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.

The Wall Street Journal on MSN · 17h

GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.

Bloomberg on MSN · 22h

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

18hon MSN

FDA Issues Risk Warning for Ice Cream Recalled in 23 States

Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes ...

8hon MSN

US FDA advisers recommend against Otsuka's PTSD combination treatment

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

16hon MSN

FDA recalls over 67,000 cases of Power Stick deodorant. See where products were sold

The manufacturer announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good ...

8hon MSN

FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak

Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...

10h

US FDA Advisers Vote Against Otsuka's PTSD Combination Treatment

(Reuters) -The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of ...

Medpage Today on MSN9h

Remove Boxed Warning on Hormone Therapy for Menopause, FDA Panel Says

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...

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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

FDA Authorizes Juul’s E-Cigarettes

GSK, FDA and Cancer Drug

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