Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a Q&A session with the Alliance for a Stronger FDA..

Sanofi is lining up to spin off the active pharmaceutical ingredients division that will include a listing as a public company, Reuters reported, citing unnamed sources.

A bill to encourage the manufacture of active pharmaceutical ingredients in America was introduced in the U.S. Senate by Senators Marsha Blackburn (R-TN) and Bob Menendez (R-NJ).

The U.S. Food and Drug Administration approved South African drugmaker Aspen Pharmacare’s hydroxyprogesterone caproate (HPC), which is used to prevent preterm birth in pregnant women.

Mallinckrodt plc agreed to sell the global biopharmaceutical company’s wholly owned subsidiary BioVectra Inc. to an affiliate of private equity investment firm H.I.G. Capital for $250 million.

The U.S. Food and Drug Administration declined to approve Aquestive Therapeutics Inc.’s erectile dysfunction treatment tadalafil and sought additional data.

Federal lawmakers are concerned that a recent cyberattack on pharma giant Merck & Co. could lead to numerous problems. including a drug shortage.

EU antitrust regulators will investigate whether Aspen Pharmacare is charging excessive prices for five key cancer drugs in a move which could lead to a hefty fine for Africa’s largest generic drugmaker.

China has signaled a tougher stance on drug quality in the country’s sprawling pharmaceuticals industry by rejecting applications for 11 medicines with inadequate or suspect clinical data. The China Food and Drug Administration (CFDA) said in statement posted on its website on Nov. 11 that the move affected eight Chinese companies making generic drugs for […]

The U.S. Food and Drug Administration warned Novartis AG last week after the Swiss firm was found in violation of manufacturing practices last year at two of its India drug-making plants, Novartis said.   The warning, issued to Novartis’s generic drugs unit Sandoz on Oct. 22, came after FDA officials inspected its Turbhe and Kalwa […]