The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...

FDA fast track designation applies to ALK+ NSCLC progressing after ≥2 ALK TKIs, reflecting limited post-lorlatinib ...

MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces ...

FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.

NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today ...

COPENHAGEN, DENMARK / ACCESS Newswire / March 18, 2026 / FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech ...

Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...

・As per Reuters, both the drugs have multibillion-dollar potential. ・FDA expects Merck to submit its applications for Enlicitide in April and for Sac-TMT in October or November next year. ・Other drugs ...

The FDA has named the first nine medications selected for its national priority review voucher program, which aims to shorten drug review timelines to as fast as two months, according to an Oct. 16 ...