Received supportive FDA feedback on key elements of the potential ELI-002 Phase 3 study design, including dose, schedule, patient population and ...

The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...

FDA halts Atara's EBVALLO and ATA3219 trials over manufacturing issues. Atara eyes $60 million milestone from Pierre Fabre upon EBVALLO approval.

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's nasal spray, Spravato, to allow it to be used ...

The Food and Drug Administration (FDA) has implemented new guidelines adjusting fees while extending the validity of the ...

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry ...

Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA inspections and global healthcare standards, driven by geopolitical shifts and ...

These forward-looking statements include, but are not limited to, those related to Cryoport receiving FDA registration for MVE Biological Solutions' manufacturing facilities, including the ...

The U.S. Food and Drug Administration on Monday set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and dry cereal, part of an effort to cut young kids’ exposure ...

During the proceedings, the secretary for schools informed the court about a newly devised provincial policy requiring all schools to adopt a school bus system as a condition for registration.

Bengaluru: In a significant move for the pharmaceutical sector, the Karnataka High Court has directed the government to abstain from taking action against companies manufacturing nutraceuticals in ...