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Tag: FDA


Cell and Gene Therapy, Industry

Astellas and Dyno Therapeutics to develop AAV gene therapy vectors

December 6, 2021

Via: European Pharmaceutical Review

Astellas Pharma and Dyno Therapeutics have announced an option and license agreement to develop next-generation adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle using Dyno’s CapsidMap™ platform. Dyno’s CapsidMap platform represents a new approach applying […]


FDA, Regulations

Merck claims another adjuvant okay from FDA for Keytruda

December 6, 2021

Via: Pharmaphorum

The US regulator has approved Keytruda (pembrolizumab) as a treatment for melanoma patents aged 12 and over with stage 2B, 2C and 3 tumours to prevent the recurrence of the cancer after the surgical removal. Moving checkpoint inhibitors further up […]


FDA, Regulations

ImmunoGen lines up FDA filing as antibody-drug conjugate shrinks tumors in pivotal trial

November 30, 2021

Via: FierceBiotech

After toiling for 40 years, ImmunoGen can now see the potential approval of its first wholly owned oncology drug on the horizon. The biotech is preparing to submit mirvetuximab soravtansine for approval after showing the antibody-drug conjugate (ADC) shrank ovarian […]


FDA, Regulations

FDA approves new imaging drug to identify ovarian cancer lesions

November 30, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally […]


FDA, News, Regulations

FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib

November 30, 2021

Via: Pharmaphorum

If approved, deucravacitinib would become the first tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease, said BMS, which is hoping to position the new drug as the treatment of choice for people with moderate to severe […]


Industry, Vaccines

Pfizer to Seek FDA Approval of Boosters for Teens Ages 16-17

November 30, 2021

Via: Drugs.com

Pfizer Inc. is expected to seek approval this week for emergency use of its booster shots among American teens ages 16-17. Sources familiar with the matter told The New York Times that the U.S. Food and Drug Administration could give […]


Industry, Vaccines

COVID-19 tracker: FDA advisory group will discuss Merck antiviral; Companies test vaccines against new variant

November 29, 2021

Via: FiercePharma

Companies are testing their COVID-19 vaccines against the new variant, omicron. An FDA advisory committee will meet tomorrow to discuss its recommendation for Merck’s COVID-19 antiviral. The worldwide case count stood at more than 261.98 million Monday afternoon, with more […]


FDA, Regulations

US FDA expands COVID-19 booster jabs to all adults

November 23, 2021

Via: PMLiVE

Previously, only people aged 65 and over and younger people at high risk of severe disease or frequent institutional or occupational exposure to the virus were eligible for a booster dose. Now, all adults can receive a booster shot six […]


FDA, Regulations

FDA, CDC COVID jab decisions ‘will simplify booster messaging’

November 22, 2021

Via: Pharmaphorum

The FDA cleared emergency use of the two vaccines on Friday, which was swiftly followed by a recommendation from a Centres for Disease Control and Prevention (CDC) advisory committee that was swiftly signed off by CDC director Rochelle Walensky. The […]


News

US government to pay $5.3bn for Pfizer‘s Paxlovid

November 22, 2021

Via: PMLiVE

The supply agreement will see the government receive ten million treatment courses of Paxlovid, pending regulatory approval, starting later in the year and into 2022. Paxlovid is a combination of PF-07321332 and ritonavir; PF-07321332 blocks the action of a protease […]


FDA, Industry, Regulations, Vaccines

Pfizer, Moderna score FDA nods for COVID boosters in all adults, setting up high-stakes CDC meeting

November 19, 2021

Via: FiercePharma

The race between Moderna and Pfizer to gain FDA nods for their COVID-19 vaccines as boosters in all adults has ended in a dead heat. On Friday morning, the FDA simultaneously expanded emergency use authorizations for both mRNA vaccines to […]


News

US President Biden nominates Robert Califf as FDA commissioner

November 16, 2021

Via: PMLiVE

Describing Dr Robert Califf as “one of the most experienced clinical trialists in the country” with more than 1,200 publications in the peer-reviewed literature, President Biden said he had both the experience and expertise to lead the FDA “during a […]