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AdComm Sets Meeting for Remicade Biosimilar Candidate
Drugmakers Team Up With Academia to Advance Preclinical Research
Immunocore Scores FDA Orphan Drug Status for Uveal Melanoma Candidate
Tracon Garners FDA Orphan Drug Status for Soft Tissue Sarcoma Candidate Read More
Calling for an immediate reform to the FDA’s opioid approval processes, Sen. Edward Markey (D-Mass.) announced he has placed a hold on the nomination of Robert Califf as the next commissioner of the agency. Read More
Shire is taking a second shot at the FDA for its eye treatment lifitegrast, resubmitting an NDA months after the agency said it needed more information before it could approve the candidate. Read More
Tuesday’s House Oversight and Government Reform Committee hearing on drug pricing has been pushed back to Feb. 4 after a weekend blizzard buried the Washington, D.C. region in snow. Read More
Lawmakers are threatening the pharmaceutical industry’s reigning bad boy Martin Shkreli with a contempt citation if he fails to show up for next week’s hearing on drug prices. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding previous inspection findings and not living up to promises to carry out proper GMP practices for active pharmaceutical ingredients. Read More
CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. Read More
With congressional efforts to pressure Gilead Sciences into lowering the price of two hepatitis C drugs floundering, members of the Senate Finance Committee are taking their concerns directly to the public. Read More