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Clinical Trial Results

SAN JOSE, Calif., April 24, 2024. Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ( Lykos ), a company dedicated to transforming ment...
FDA Daily Update

Most postmarketing requirements (PMR) and postmarketing commitments (PMC) for NDAs and BLAs were on-schedule in 2022, according to figures just rel...
FDA Daily Update

With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-e...
FDA Daily Update

Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases to apply for accelerated approval (AA) to give the pro...
FDA Daily Update

Answers to questions biologics companies may have when developing promotional communications for prescription biologics including reference product...
Clinical Trial Results

NORTHBROOK, Ill., April 23, 2024 - Endevica Bio, a company developing first-in-class peptide drug candidates, announced its novel weight-loss treat...
Drugs FDA Alerts

Audience: Healthcare Provider, Pharmacy, Consumer Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today annou...
FDA Daily Update

Identifying and reducing production and delivery vulnerabilities are the focus of the European Medicines Agency’s (EMA) recent recommendations to e...
FDA Daily Update

Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showi...
FDA Daily Update

Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA ann...
FDA Daily Update

Two pharmaceutical giants based in Japan — Takeda and Astellas — have signed a master agreement along with Sumitomo Mitsui Banking Corporation to e...
New Drug Applications

CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikerac...