Food and Drug Administration (FDA)

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23.06.2023 • News

US Senators Seek Answers on Drug Shortages

In what is being billed as a bipartisan effort to address shortages along the US pharmaceutical supply chain, two senators — one Democrat, one Republican — have introduced legislation that calls for an investigation of the problems and development of a plan to reduce the country’s dependence on imported drugs.

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07.06.2023 • News

FDA Allows Oncology Drug Imports amid Shortage

To boost supply of the injectable chemotherapy drug cisplatin – the US is facing a shortage of oncology treatments – the Food and Drug Administration (FDA) will temporarily allow imports of 50-milligram vials from Chinese manufacturer Qilu Pha. Canada’s Apotex would distribute.

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16.05.2023 • News

Positive Vaccine Data Bolster Novavax

The market value of US vaccine maker Novavax is gaining momentum again on the back of promising data the company recently provided on its combined Covid and flu vaccine data.

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24.04.2023 • News

All US Mifepristone Moves on Hold for now

All immediate challenges to the status of abortifacient mifepristone on the US market are on ice for the near future after the Supreme Court on Apr. 21 — without considering the merits of the case — approved a Justice Department request to put temporarily suspend recent rulings by a federal district court and an appeals court.

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17.04.2023 • News

US Anti-Mifepristone Decision on Hold for Now

All changes to the US use of abortifacient mifepristone are now on hold – for three more days – pending a review by Supreme Court Justice Samuel Alito of two complex and differing lower court decision on lawsuits brought by anti-abortion groups.

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20.01.2023 • News

New FDA Rules Allow OTC Sales of Abortion Drugs

At the beginning of 2023, the US Food and Drug Administration (FDA) stepped into a political hornet’s nest with its decision to allow retail pharmacies to dispense abortion pills over the counter. It is now fighting the backlash, so far successfully.

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02.09.2022 • News

FDA Grants EUAs to Omicron-targeted Covid Shots

As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA vaccine makers Pfizer-BioNTech and Moderna.

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04.08.2022 • News

CSL Close to Finally Taking Control of Vifor

Australian biopharma CSL said this week it has received all the regulatory clearance required to take over Switzerland’s Vifor. The acquisition announced in December 2021 temporarily stalled in May 2022.

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13.07.2022 • News

US Government Buys 3 Million Novavax Doses

The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have ordered 3.2 million doses of Novavax’s Covid-19 vaccine, even before the protein-based and adjuvanted shot has cleared the US Food and Drug Administration.

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09.06.2022 • News

FDA Panel Recommends Approval of Nuaxovid

In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine Nuaxovid for emergency use. If the health agency agrees, it would be the fourth such shot available in the US, joining the mRNA products of Pfizer/BioNTech and Moderna and the viral vector shot of Johnson & Johnson’s pharma subsidiary Janssen.

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07.06.2022 • News

FDA Greenlights GSK’s MMR Vaccine

The US Food and Drug Administration (FDA) has greenlit GSK’s Priorix-branded GSK’s mumps and rubella vaccine (MMR) for people 12 months and older. It is only the second such shot to be licensed for US distribution in more than 50 years. Merck & Co’s MMR-II vaccine was approved by the FDA for the pediatric application in 1971.

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13.05.2022 • News

FDA Restricts Use of J&J Covid Vaccine

US health authorities are restricting the use of the Johnson & Johnson Covid vaccine somewhat belatedly, citing the rare blood clotting issues that have dogged this vaccine from the start, as well as the AstraZeneca shot.

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07.04.2022 • News

CDC and FDA Sideline Last Covid Antibody Treatment

The US Centers for Disease Control and the Food and Drug Administration have removed the IV antibody treatment sotrovimab made by GlaxoSmithKline (GSK) and Vir Biotechnology from the list of approved drug therapies for Covid-19.

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22.03.2022 • News

FDA Panel Meeting to Discuss Covid Vaccine Boosters

The US Food and Drug Administration has scheduled a virtual meeting of its scientific advisory panel for Apr. 6 to discuss the prospect of future Covid-19 boosters and the process for updating existing vaccines. The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) will participate.

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16.02.2022 • News

US Senate Confirms Califf as FDA Commissioner

The US Food and Drug Administration (FDA) finally has a new commissioner, after 391 days of interim leadership. In a narrow vote of 50 to 46 on Feb. 15, the Senate confirmed Robert Califf to the top job, which has been vacant since January 2021.

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03.12.2021 • News

FDA Advisory Panel Narrowly Votes for Lagevrio EUA

With a vote of 13 to 10, the Antimicrobial Drugs Advisory Committee, an advisory panel to the US Food and Drug Administration, narrowly decided to to recommend emergency use authorization (EUA) of the Covid-19 antiviral pill molnupiravir (brand name Lagevrio) developed by US drugmaker by Merck &Co together with compatriot Ridgeback Biotherapeutics.

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23.11.2021 • News

Biden Taps Califf to Return as FDA Commissioner

US president Joe Biden has nominated Robert M. Califf to return to the job he once held as commissioner of the Food and Drug Administration (FDA). In a statement, Biden – who had been criticized for not naming a new FDA chief sooner, said Califf “has the experience and expertise to lead FDA during a critical time in our nation’s fight to put an end to the coronavirus pandemic.”

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24.09.2021 • News

FDA Takes Panel’s Advice on Covid Vaccine Boosters

Acting quickly after its advisory panel published its guidance, the US Food and Drug Administration (FDA) on Sept. 22 announced it was amending its Emergency Use Authorization (EUA) for Pfizer/BioNTech’s Covid-19 vaccine to allow a booster dose to be administered at least six months after completion of the primary series.

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20.09.2021 • News

FDA Advisory Panel Backs Boosters for Most Vulnerable

In a 16-2 vote, the US Food and Drug Administration’s advisory panel on Sept. 17 recommended against supporting president Joe Biden’s plans to offer a booster dose of the Pfizer/BioNTech Covid-19 vaccine to everyone over 16 years of age. In the two-pronged decision, the panel said it would recommend a third dose only for those older than 65 and the immunocompromised.

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03.09.2021 • News

Two FDA Vaccine Experts Quit over Covid Boosters

Two key vaccine officials of the US Food and Drug Administration (FDA) plan to quit the agency over the next three months in protest against President Joe Biden’s plan to offer Covid-19 booster shots to all Americans starting this month, even if they only received their second shot five months earlier.

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25.10.2020 • News

US Health Secretary Targeting FDA Chief?

Alex Azar, US Secretary of Health and Human Services (HHS), is rumored to be plotting for the Trump administration to oust FDA Commissioner Stephen Hahn in retaliation for the health agency’s issuing its own guidance for approving a Covd-19 vaccine independently of the White House.

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07.10.2020 • News

White House Won’t Block FDA Vaccine Guidelines

The administration of US president Donald Trump said on Oct. 6 it planned to override the tightening of safety precautions for Covid-19 vaccine proposed by the Food and Drug Administration (FDA) two weeks ago, over fears these could delay approval. Later in the day, it did an unexplained about-turn after the FDA published the guidelines on its own website as part of a briefing for outside vaccine advisers.

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25.09.2020 • News

Trump Says he Could Override FDA Vaccine Standards

US president Donald Trump has said he believes the White House could override the US Food and Drug Administration (FDA) if the national health watchdog goes ahead with mooted plans to toughen standards for approval of a Covid-19 vaccine or an Emergency Use Authorization.

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23.09.2020 • News

FDA may Issue Tougher EUA Standards

Amid worries in the American public that an unsafe vaccine could be approved by the US Food and Drug Administration just in time for the Nov. 3 election, the FDA reportedly will impose new, tougher, standards for an emergency authorization (EUA) of a coronavirus vaccine.

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