BioSpace News Archive

Palvella Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).

Catalyst Pharmaceuticals, Inc. today announced that Patrick J. McEnany, Chairman and CEO of Catalyst, along with other members of the management team, will participate at the upcoming Piper Sandler 35th Annual Healthcare Conference.

Lighthouse Pharmaceuticals today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for LHP588, the company’s next-generation gingipain inhibitor, for the treatment of P. gingivalis-positive Alzheimer’s disease.

Syndivia is excited to announce the appointment of Nobel Prize-winning chemist, Professor Jean-Marie Lehn , as the Chairman of the company’s Scientific Advisory Board (SAB).

Ensysce Biosciences, Inc. today announced that the PF614-201 study, & A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects’ has completed enrollment.

Apollomics Inc. today announced that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).

Curium announced that in partnership with its exclusive distributor SYN Innovation Laboratories in Greece, the first patients in Greece have been injected with PYLCLARI® also known as -DCFPyL, indicated for the detection of prostate-specific membrane antigen positive lesions with positron emission tomography in patients with prostate cancer in the following clinical settings:

Epic Bio, a biotechnology company developing therapies to modulate gene expression using compact, non-cutting dCas proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EPI-321 for the treatment of facioscapulohumeral muscular dystrophy (FSHD), the most common form of muscular dystrophy in adults.

Theravance Biopharma, Inc. announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society, taking place November 15-18, 2023, in Rio Grande, Puerto Rico.

Fusion Pharmaceuticals Inc., and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc., announced that the companies have entered into a new agreement for the supply of generators to produce actinium-225, a medical isotope used to treat cancer in clinical trials.