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endometriosis

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 …

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diabetes

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. …

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diabetes

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 …

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Antares

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 injection. …

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booster

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 …

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children

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, …

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biotech

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 …

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approval

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 removed …

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atrophy

Roche’s aim to widen Evrysdi’s label nabs speedy FDA review in young spinal muscular atrophy patients

Now poised for a speedy trip through the FDA’s regulatory review, Roche’s oral challenger in spinal muscular atrophy (SMA) could soon pick up a nod …

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diagnosed

Idorsia scores FDA go-ahead for insomnia drug Quviviq to rival Merck’s Belsomra, Eisai’s Dayvigo

The FDA blessed Idorsia’s Quviviq (daridorexant), a sleeping pill for those with insomnia. Because the FDA has recommended Idorsia to register Quviviq as a controlled substance, the …

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