The company shifted attention in March from its big acne setback to its mid-year Qbrexza approval, so with a recent FDA nod for the hyperhidrosis treatment, Dermira will fill out its sales team and make the topical product for excessive underarm sweating available in October.
Dermira Inc. claimed an important victory when it won US FDA approval for Qbrexza (glycopyrronium) – a topical anticholinergic delivered by a cloth wipe – on June 29 for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients aged 9 and older.
The agency's decision marks the company's first-ever drug approval and it provided the Menlo Park, Calif., company with a needed...
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Lynkuet will compete with Astellas's Veozah/Veoza
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
