The Caledonian-Record

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with ...

Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Camzyos (mavacamten) as a potential treatment for ...

Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product

Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the ...

US FDA approves AbbVie's rare blood cancer drug

(Corrects to clarify the total number of patients in the study in paragraph 10) May 27 (Reuters) - The U.S. Food and Drug ...
JD Supra

FDA one-day inspections pilot: What to expect and how to prepare

The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional ...

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...

Food and Drug Administration

CBS News legal contributor Jessica Levinson breaks down the ruling. The Trump administration's push for FDA approval of fruit ...

FDA finds high levels of mercury and hydroquinone in skin lightening products

FDA warns against using over-the-counter skin lightening products due to high levels of mercury or hydroquinone, which can ...

U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plant

By Rishika Sadam May 29 (Reuters) - The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following an inspection ...

Trump’s FDA chief is out after angering pharma CEOs, vaping lobbyists and anti-abortion activists

Marty Makary is resigning as President Donald Trump's Food and Drug Administration chief. The surgeon and health researcher's tenure had drawn complaints from pharmaceutical executives, anti-abortion ...