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Volume 16 Issue 2
 
Volume 15 Issue 4

FDA Focus on the Safety of Gene Therapy Products

Within the past 6 years, the US Food and Drug Administration (FDA) has approved a growing number of cellular and gene therapy products to treat a variety of conditio...
24 January 2024 Volume 15 Issue 4 Drug Administration | Dystrophy
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Volume 14 Issue 6

Recent FDA Advancements in Rare Diseases – Funding, Partnerships, and Programs

The paucity of therapeutic choices is a reality often acknowledged by the US Food and Drug Administration (FDA) as it reviews applications for new medical products or...
30 November 2022 Volume 14 Issue 6 applications | approved
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Regional News

Myovant, Pfizer’s expansion bid for Myfembree hits a snag at the FDA

Myovant and Pfizer’s endometriosis expansion bid for Myfembree has hit a pothole late in the FDA’s review process. In a letter to the companies, the United States...
13 April 2022 Regional News endometriosis | FDA
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Regional News

Novo Nordisk, trying to switch patients to Rybelsus, launches new TV ad

Down with Rybelsus! No, this isn’t a line from "1984," but rather the new message from Novo Nordisk for its first Rybelsus ad of 2022. One of the biggest issues f...
4 April 2022 Regional News diabetes | FDA
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Regional News

Zealand becomes a lesson in the rigors of commercialization as a slow launch triggers 90% staff cut, CEO exit

It wasn’t supposed to be this way. Zealand Pharma should be in the honeymoon glow of its first drug launch with a drug approved less than a year ago. Instead, it's lo...
4 April 2022 Regional News diabetes | FDA
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Regional News

Antares, Lipocine expand testosterone therapy offerings with FDA nod for a new, oral med for hypogonadism

In 2018 with Xyosted, Antares brought to the market a user-friendly testosterone replacement therapy for hypogonadism, with the drug administered at home by weekly in...
30 March 2022 Regional News Antares | FDA
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Regional News

After FDA green lights a second COVID booster, official says another could come in the fall

A few hours after the FDA authorized a fourth dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines, one of its top experts hinted that a fifth dose may be on its...
30 March 2022 Regional News booster | COVID
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Regional News

Moderna seeks FDA nod for COVID vaccine in children under 6, starts delayed filing for older kids

Moderna has new data backing the use of its COVID-19 vaccine Spikevax at a low dose in the youngest children under the age of 6, and it’s moving forward with global r...
23 March 2022 Regional News children | COVID
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Regional News

Novavax finally submits its COVID-19 vaccine to the FDA. Is it too late?

It's finally here: After a series of delays in the lead-up to Novavax's COVID-19 vaccine filing with the FDA, the biotech has completed its emergency use authorizatio...
2 February 2022 Regional News biotech | COVID-19
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Regional News

GlaxoSmithKline’s HIV drug Cabenuva scores FDA nod for 2-month dosing

Last January, when GlaxoSmithKline’s ViiV Healthcare won a long-awaited approval for its long-acting HIV treatment Cabenuva, it was hailed as a game-changer as it rem...
2 February 2022 Regional News approval | dosing
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