Denali Therapeutics faces an FDA review delay for its Hunter syndrome drug, pushing potential approval of tividenofusp alfa to April 2026.

The disease gradually takes away the skills children have learned—leading to seizures, movement difficulties and profound ...

Detailed price information for Spruce Biosciences Inc (SPRB-Q) from The Globe and Mail including charting and trades.

Spruce Biosciences shares soared after the FDA granted Breakthrough Therapy Designation to its lead treatment for Sanfilippo Syndrome Type B.

Spruce Biosciences shares reached a 52-week high after a drug update and favorable comments on X by Martin Shkreli. Spruce said the Food and Drug Administration granted Breakthrough Therapy ...

Shares of Spruce Biosciences, Inc. (NASDAQ: SPRB) are surging Monday after the biotech company shared an important regulatory ...

Investing.com -- Spruce Biosciences (NASDAQ:SPRB) stock surged 60% after the company announced it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its ...

JCR and MEDIPAL announced that the Ministry of Health, Labour and Welfare of Japan has granted orphan drug designation to JR-446 for MPS IIIB.

MEDIPAL HOLDINGS CORPORATION (TSE 7459, MEDIPAL) and JCR Pharmaceuticals Co., Ltd. (TSE 4552, JCR) today announced that the Ministry of Health, Labour and Welfare of Japan has granted orphan drug ...

KNOXVILLE, Tenn. — Bryan and Blair Begbie said all they want for Rowan — their youngest daughter — is the chance to be a kid. However, the Food and Drug Administration issued what is called a Complete ...