Tag: regulatory approval

Châtillon, France, June 2, 2026

- The INDIGO study met its primary and all key secondary endpoints with statistically significant results -

POWER1 Study in highly refractory patients with focal onset seizures did not meet its primary success measure

Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ^®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada¹ and complements the adolescent label extension received in Europe in April 2025².

NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Biohaven Ltd. (“Biohaven” or the “Company”) (NYSE: BHVN) and certain officers. The class action, filed in the United States District Court for the District of Connecticut, and docketed under 25-cv-01120, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biohaven securities between March 24, 2023 and May 14, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 sand Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy^® (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity.

   
- Successfully initiated enrollment in advanced Phase 2 ovarian cancer trial

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

CINCINNATI, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Workhorse Group Inc. (Nasdaq: WKHS) (“Workhorse” or “the Company”), an American technology company focused on pioneering the transition to zero-emission commercial vehicles, today reported financial results for the second quarter ended June 30, 2025.

First-in-human study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102, an orally available small molecule with potential best-in-class profile

Joins Workhorse’s proven vehicles, manufacturing capabilities and national dealer network with Motiv’s diverse product portfolio and top fleet relationships

SOUTH SAN FRANCISCO, Calif., Aug. 15, 2025 (GLOBE NEWSWIRE) --  Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, “Company”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 42,300 shares of the Company’s stock (the “Inducement Grant”) to newly hired employees on August 12, 2025 (the “Grant Date”), in connection with the commencement of employment.