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Food and Drug Administration (FDA)

Kimberly Redmond | Equities.com |

The US Food and Drug Administration (FDA) is allowing Emergent BioSolutions Inc (NYSE: EBS) to resume production of Johnson & Johnson's (NYSE: JNJ) COVID-19 vaccine at the Baltimore facility that was shut down earlier this year due to contamination concerns.

The plant, which had been contracted by both J&J and AstraZeneca plc (NYSE: AZN), has been offline since April after ingredient mix-ups ruined 75 million doses.


Kimberly Redmond | Equities.com |

The US Food and Drug Administration (FDA) has agreed to a “priority review” of Pfizer-BioNTech’s COVID-19 vaccine for a full approval decision by January 2022.

According to FDA commissioner Dr. Janet Woodcock, action will likely come much sooner because regulators consider the review “among the highest priorities of the agency.”


AP News | Equities.com |

A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use.

The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month.


Reuters | Equities.com |

U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.

The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.


Reuters | Equities.com |

Orphazyme slashed its financial forecasts on Friday after U.S. health regulators rejected its key drug candidate, sending shares in Denmark’s first so-called meme stock tumbling 75% in early trading.

Shares in the biotech company, which has yet to have a drug approved or make money, have been on a roller-coaster recently — like other "meme stocks" influenced by chatter on social media — as investors took positions ahead of the U.S. Food and Drug Administration's (FDA) decision.


AP News | Equities.com |

Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by six weeks.

The company said a Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months. In February, the FDA originally authorized J&J’s vaccine for up to three months when stored at normal refrigeration levels.


Kimberly Redmond | Equities.com |

Moderna Inc (Nasdaq: MRNA) is asking the US Food and Drug Administration (FDA) for full approval of its COVID-19 vaccine for people age 18 and up, the company announced Tuesday.

The Massachusetts-based drugmaker began distributing its experimental double-dose vaccine in December 2020 under an FDA emergency use authorization (EUA), a temporary approval from regulators that requires only two months of clinical data.


Kimberly Redmond | Equities.com |

In an effort to curb smoking rates, the US Food and Drug Administration (FDA) announced Thursday it plans to eventually institute a ban on menthol tobacco cigarettes and flavored cigars.

In a press release announcing its decision, the FDA said the move is “based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.”


Kimberly Redmond | Equities.com |

White House chief medical advisor Dr. Anthony Fauci said that he expects US regulators to make a decision on lifting the pause on Johnson & Johnson's (NYSE: JNJ) COVID-19 vaccine this coming Friday when an expert advisory panel of the US Centers for Disease Control and Prevention (CDC) meets.

Fauci said on CNN's "State of the Union" program on Sunday that he expects the experts to recommend “some sort of either warning or restriction” on the use of J&J's vaccine after their analysis of the data is completed.


AP News | Equities.com |

Johnson & Johnson’s COVID-19 vaccine will remain in limbo for a while longer after government health advisers declared Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the risk really is.

The reports are exceedingly rare — six cases out of more than 7 million U.S. inoculations with the one-dose vaccine. But the government recommended a pause in J&J vaccinations this week, not long after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S.