Regulatory

According to Amneal Pharmaceuticals, the FDA has tentatively approved Amneal’s ANDA for a generic of Teva’s QVAR beclomethasone dipropionate HFA MDI, 40 μg/actuation and 80 μg/actuation, for the treatment of asthma. The company notes that… Read more . . .

Italian biotech Dompé announced that the US FDA has awarded a voucher under the new Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated review of an application for the company’s intranasal cenegermin-bkbj (recombinant human… Read more . . .

According to Beckley Psytech and atai Life Sciences, the FDA has granted Breakthrough Therapy designation to Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. Earlier this year, the companies announced that a Phase… Read more . . .

The FDA has granted 510(k) clearance to Aptar Digital Health’s HeroTracker Sense MDI sensor, the company said. Aptar acquired the sensor’s developer, Cohero Health, in 2020 and launched the Bluetooth-enabled sensor in 2022. According to the… Read more . . .

According to Chiesi, the FDA has accepted the company’s NDA for its CHF5993 beclomethasone dipropionate /formoterol fumarate / glycopyrrolate MDI for the treatment of asthma. In April 2024, Chiesi announced that it was initiating a… Read more . . .

MannKind Corporation announced that the FDA has accepted the company’s sBLA for the use of Afrezza inhaled dry powder insulin in diabetes patients aged 4 to 17 and has set a PDUFA date of May 29, 2026.… Read more . . .

According to ARS Pharmaceuticals, both the US Patent and Trademark Office and the European Patent Office have upheld the validity of claims in patents related to neffy epinephrine nasal spray / EURneffy adrenaline nasal spray.… Read more . . .

Polyrizon announced that it has submitted a pre-submission package to the FDA for its PL-14 Allergy Blocker nasal spray. The company describes the product as “a novel, non-invasive nasal spray that forms a physical barrier… Read more . . .

According to ARS Pharmaceuticals, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved 1mg and 2mg doses of neffy epinephrine nasal spray for the treatment of anaphylaxis in people who weigh more than 15 kilograms.… Read more . . .

AstraZeneca announced that the FDA has approved the company’s supplemental NDA to add data related to the treatment of mild asthma to the label for Airsupra albuterol / budesonide MDI. In October 2024, AstraZeneca and… Read more . . .