Approvals
The FDA has approved Incyte’s Opzelura as the first and only at-home therapy for repigmentation in nonsegmental vitiligo.
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
The granting of the EUA comes with certain limitations, as the prescribing pharmacist must refer patients for clinical assessment with a physician.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
BMS’ CAR-T therapy Breyanzi picked up a second approval from the FDA. The cancer drug was approved for the treatment of adult patients with large B-cell lymphoma.
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
Gelesis’ weight loss device, Plenity, has been gaining popularity since the FDA approved its commercialization, but some in the medical community question whether its popularity is deserved.
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Thursday, a committee of advisors for the CDC voted unanimously for children and teens, ages six to 17 to receive Moderna’s COVID-19 vaccine.
The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
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