Food and Drug Administration (FDA)
NEWS
A look at the FDA’s long-awaited guidelines on how it will regulate regenerative medicine products, including stem cells.
A look at the 19 spine-related medical devices the FDA cleared in October.
PellePharm is aiming to launch Phase III trials of the topical hedgehog inhibitor in early 2018.
The company is weeks away from completing its rolling NDA for Patisiran.
The FDA approved a label expansion for Pfizer’s cancer drug Sutent to include the adjuvant treatment of adult patients at high risk of RCC following the surgical removal of the cancerous kidney.
Genentech scored two approvals from the FDA this week.
The company said it received the letter on November 9 based on an inspection of its facilities from April and that it is preparing an appropriate response to the letter.
The FDA issued warning letters to Lupin for two of its manufacturing facilities in Goa and Pithampur, Indore.
The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.
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