Pharmacologic Substance
FDA Shakeup: Peter Marks’ Resignation Rattles Biotech Industry
Peter Marks, FDA resignation, biotech stocks, regulatory uncertainty, drug approvals
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug
CHMP, Labels (device), expansions, Approved
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
BioNTech shows off lung cancer survival data behind phase 3 push for red-hot bispecific
BNT327, BioNTech, month, BioNTech ‘s, Small cell carcinoma of lung, Pharmacotherapy
BioAtla lays off 30% of staff, hunts out partners for ADC and cancer antibody
Staff, Partner in relationship, CAB, BioAtla, 30%
Merck’s Injectable Keytruda Shows Promising Results in Pivotal Trial
Keytruda, subcutaneous injection, intravenous formula, non-small cell lung cancer, pivotal trial, Merck
Equillium’s pivotal GvHD study of anti-CD6 antibody comes up short
United States Food and Drug Administration, itolizumab, In complete remission, day, Equillium
Alcon Secures Control of Aurion Biotech in Strategic Takeover
Alcon, Aurion Biotech, majority stake, CEO replacement, cell therapy, corneal endothelial disease, AURN001, IPO dispute
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
FDA approval, Vykat XR, Prader-Willi syndrome, hyperphagia, Soleno Therapeutics, diazoxide choline
FDA clears Exelixis’ TKI for neuroendocrine tumours
CABOMETYX, cabozantinib, neuroendocrine tumors, FDA approval, Exelixis, tyrosine kinase inhibitor