The FDA has sent its third warning letter in three months to facilities making homeopathic meds, raising concerns about potentially toxic ingredients.
Four weeks after Germany pulled the manufacturing authorization for a Dr. Reddy’s plant in India, it has blocked a second one.
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
Biocon says it has won EMA manufacturing approval for a $275 million plant in Malaysia where it will make insulin for export to the EU.
The FDA has issued a scathing warning letter to a Pfizer unit that produced EpiPens that failed during emergencies, some of them fatal.
Brought to you by the publisher of FierceBiotech and FiercePharma, the Fierce Innovation Awards Life Sciences Edition identify and showcase outstanding…
New Jersey-based CDMO Catalent signed a deal with US WorldMeds to manufacture lofexidine, an investigational drug used to treat opioid withdrawal.
The FDA is reorganizing its manufacturing inspections, saying the new system should speed drug approvals and reduce surprises for drugmakers.
Mylan and Biocon, whose Herceptin biosimilar was to be considered by the FDA Sept. 3, has had its target date delayed three months.
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.