Checkpoint said in July that the FDA accepted for review its resubmission of the Biologics License Application for the drug and set a Prescription Drug User Fee Act goal date of Dec. 28. Shares were ...

The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.

Checkpoint said in July the FDA accepted for review its resubmission of the Biologics License Application and set a Prescription Drug User Fee Act goal date of Dec. 28. The agency issued a Complete ...

Outlook Therapeutics (OTLK) announced that following an internal strategic review, the management team and board of directors have implemented ...

Full NORSE EIGHT Data Readout Expected January 2025ISELIN, N.J., Dec. 13, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union ...

Candel shares are moving lower on Friday after the company priced its $80 million underwritten public offering of shares and ...

Levi & Korsinsky, LLP notifies investors in Humacyte, Inc. ("Humacyte, Inc." or the "Company") of a class action securities ...

On the morning of2, 2024 (UTC-6), at the Poster Spotlight Session "Novel HER2 Therapeutics" of the 47th San Antonio Breast Cancer Symposium (SABCS), RemeGen Co. Ltd. ("RemeGen") (9995.HK, 688331.SH) ...

Adding tafasitamab to treatment with lenalidomide and rituximab improved progression-free survival in patients with relapsed or refractory follicular lymphoma.

14 The U.S. FDA's review of Galderma's Biologics License Application for nemolizumab for the treatment of moderate-to-severe atopic dermatitis is currently ongoing, with a decision anticipated soon.

Prurigo nodularis is a serious skin condition characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality. 5-7,10 The ...