Food and Drug Administration (FDA)

Skippy Recalls Over 161,000 Pounds of Peanut Butter for Possible Steel Fragments

Equities Staff | |

The company, a unit of Hormel Foods (HRL), is the second largest seller of peanut butter worldwide.

SIGA Technologies Reports $115 Million in Q4 Revenue

Edward Kim | |

The company sold $113 million of its smallpox therapeutic to the US government.

Ardelyx Secures $27.5 Million Debt Financing From SLR Capital

Edward Kim | |

The funds come at a critical time for the embattled biotech.

TG Therapeutics Tumbles 40% on Partial Clinical Trial Hold

Edward Kim | |

Shares of TG Therapeutics (TGTX) got slammed Thursday after CEO Michael Weiss disclosed that the FDA had placed a partial hold on the company's Phase 3 trial  lost 40.5% of their value Thursday on nevaluating the investigational U2 combination (UKONIQ® (umbralisib) and ublituximab) compared to the control arm of obinutuzumab plus chlorambucil and that the FDA imposed a partial clinical hold on select studies of U2 and its components for chronic lymphocytic leukemia (CLL) ...

FDA Expands Booster Dose Usage Authorization for COVID-19 Vaccines

Kimberly Redmond | |

The US Food and Drug Administration (FDA) signed off Wednesday on extending COVID-19 boosters to the millions of Americans who received the Moderna Inc (Nasdaq: MRNA) or Johnson & Johnson (NYSE: JNJ) vaccines and said anyone eligible for an extra shot can mix and match doses from different drug providers.

Specifically, regulators amended the emergency use authorizations to permit a half dose of Moderna’s vaccine as a booster shot for seniors and others at high risk from the virus six months after their last shot.

Merck Seeks FDA Emergency Authorization for First Oral COVID-19 Therapy

Kimberly Redmond | |

Drugmaker Merck & Co Inc (NYSE: MRK) and its partner Ridgeback Biotherapeutics LP announced Monday that they have requested an emergency use authorization from the US Food and Drug Administration (FDA) for their oral antiviral COVID-19 treatment.

If approved, the pill, molnupiravir, would be the first oral therapy for COVID-19 and could be a potential breakthrough on how the virus is treated since all other FDA-backed treatments require an injection or IV.

Pfizer-BioNTech Ask FDA to Authorize COVID-19 Vaccine for Children 5 to 11

Kimberly Redmond | |

Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced Thursday they have asked the US Food and Drug Administration (FDA) to expand their COVID-19 vaccine’s emergency use authorization to cover children ages five to 11.

If authorized, this would be the first coronavirus vaccine authorized for younger children. Currently, the Pfizer-BioNTech shots are only approved in the US for people ages 16 and up and in the EU for people ages 12 to 15.

Pfizer, BioNTech To Seek Emergency Use Authorization for COVID-19 Vaccine in Children Under Five

Kimberly Redmond | |

Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) expect to seek emergency use authorization from the US Food and Drug Administration by November for their COVID-19 vaccine to be administered to children younger than five years old.

During the Morgan Stanley Global Healthcare Conference on Tuesday, Pfizer’s chief financial officer Frank D’Amelio said the drugmaker is awaiting results of pediatric trials of the vaccine, which should be available over the next month.

FDA Approves Pfizer-BioNTech COVID-19 Vaccine

Kimberly Redmond | |

The US Food and Drug Administration (FDA) approved Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 and older on Monday.

The approval had been originally targeted for Labor Day but was expedited due the recent surge of the more infectious Delta variant of the virus, according to The New York Times.

FDA Authorizes COVID-19 Vaccine Boosters for Immunocompromised People

Reuters | |

The U.S. Food and Drug Administration on Thursday authorized a booster dose of COVID-19 vaccines from Pfizer Inc and Moderna Inc for people with compromised immune systems.

A few other countries, such as Israel and Germany, plan to or have already administered the third shot to avoid another crisis due to the contagious Delta variant of the coronavirus.

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