Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.
Category: Food and Drug Administration
-
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
The New York Times – Business: -
Vaccine Makers Curtail Research and Cut Jobs
The New York Times – Business:Federal policies under Robert F. Kennedy Jr. that are hostile to vaccines have “sent a chill through the entire industry,” one scientist said.
-
U.S. Health Officials Defend Rejection of Moderna’s Flu Vaccine
The New York Times – Business:The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency.
-
’Shrooms Lead the Pack in Psychedelic Medicine, but Rollout Is Bumpy
Psilocybin-assisted therapy is legal in three states, but access has so far been limited and expensive.
-
‘Chinese Peptides’ Are the Latest Biohacking Trend in the Tech World
The gray-market drugs flooding Silicon Valley reveal a community that believes it can move faster than the F.D.A.
-
F.D.A. Turmoil Keeps Spotlight on Its Commissioner
The agency’s high-level turnover and conflicting policy decisions on drug oversight have fueled concerns about the leadership of Dr. Marty Makary.
-
F.D.A. Approves Two New Drugs to Treat Gonorrhea
The sexually transmitted disease has become increasingly resistant to existing antibiotics.
-
FDA Expands Covid Vaccine Inquiry to Adult Deaths
The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the assertions.
-
F.D.A. Attributes 10 Children’s Deaths to Covid Vaccines
The agency’s top vaccine regulator said that a review had found that the children were likely to have died “because of” the shots. But public health experts want to examine the data.
-
Botulism Bacteria Found in Infant Formula, ByHeart Confirms
ByHeart, the maker of the product, has been linked to an outbreak of illnesses among infants that led to their hospitalizations.
-
F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths
A gene therapy for Duchenne muscular dystrophy caused complications to the liver, prompting a review of its use for younger patients.
-
Kennedy Walks a Tightrope on Trump Deal for Obesity Drugs
The weight loss medicines are proving to be a test case for Robert F. Kennedy Jr., the health secretary, in straddling divisions between his supporters and the president.