The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment…
Spectrum Pharmaceuticals, receiving yet another blow from the FDA on its cancer therapy candidate, poziotinib, has announced that it will drop its poziotinib program and is laying off 75 percent…
Axsome Therapeutics’ proprietary combination of dextromethorphan and bupropion — already approved for major depressive disorder as AXS-05 — also reduced the risk of agitation related to Alzheimer’s disease (AD), the…
Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s…
The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product. Source: Drug…
Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its…
CSL Behring has won FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a gene therapy with the potential to cure hemophilia B and — at $3.5 million per treatment — the most…
Three union pension funds have filed a class action antitrust suit against Bristol Myers Squibb (BMS) and several generic drugmakers claiming the companies conspired to restrict competition on blockbuster blood…
The FDA is proposing to add arginine hydrochloride (HCl) and lysine HCl to its 503B Bulks List of active pharmaceutical ingredients approved for compounding. Source: Drug Industry Daily
Newly proposed bipartisan legislation would require the Drug Enforcement Administration (DEA) to reclassify psilocybin and MDMA (“Ecstasy”) from Schedule I to Schedule II drugs, relaxing some of the federal laws…