Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ...

Standard components of the forms include the subject name, subject study number, and the names and contact information of the authorized prescribers of the study drug. The drug name, dosage ...

FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider, the ...

The U.S. Food and Drug Administration said on Friday it has approved AstraZeneca's nasal spray flu vaccine for ...

Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday.

Jennifer Nosek alleges in a complaint that midwife Heather Baker gave her a "homeopathic" that was actually the drug ...

Wednesday, the FDA approved Merck & Co Inc’s (NYSE ... MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest. The approval is based on pivotal Phase 2/3 IND.

She was sentenced to a 10-month ICO and ordered to complete 75 hours of community service for faking the medical certificates. She was also convicted of the drug offences, fined $750, and ...

So when the lights appear to flicker or she sees an aura — sure signs a migraine is imminent — she says she’ll reach for ...

Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025 ...

"Are suicide and drug-related related deaths among gay men becoming normalised?" asks social psychologist and expert in ...

The approval marks first indication for Keytruda in MPM in the US, MPM is a rare, aggressive cancer around the lining of the lungs and chest Wednesday, the FDA approved Merck & Co Inc’s MRK ...