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FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases WorldPharmaNews
October 29, 2021
The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies...
FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases EuropeanPharmaceuticalReview
October 29, 2021
The US Food and Drug Administration (FDA), the National Institutes of Health (NIH), 10 pharmaceutical companies and five non-profit organisations have partnered to accelerate development of gene therapies for rare diseases.
FDA Holds Workshop to Discuss the Safe Use of Benzodiazepines FDA
October 29, 2021
FDA continues to focus on the safe use of benzodiazepines. One critical element of increasing our understanding of their benefits and risks is through collaborations and stakeholder outreach.
FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for Ovarian Cancer Treatment AmericanPharmaceuticalReview
October 28, 2021
Alkermes plc announced that the FDA has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy...
FDA declines approval of United Therapeutics’ Tyvaso after inspection issue CPhIonline
October 22, 2021
The US Food and Drug Administration has declined to approve United Therapeutics’ Tyvaso (Treprostinil) dry powder inhalation drug-device combination treatment for pulmonary arterial hypertension...
Xtrava Health Receives Emergency Use Authorization for their Rapid SPERA™ COVID-19 Ag Test prnasia
October 22, 2021
Xtrava Health, a health technology company, today announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for their SPERA™ COVID-19 Ag Test.
FDA Selects Aetion Evidence Platform® to Advance Regulatory Science and Innovation prnewswire
October 22, 2021
Today, Aetion announces that it is expanding its relationship with the U.S. Food and Drug Administration (FDA) to use real-world evidence (RWE) to study COVID-19 interventions and advance regulatory science and innovation.
FDA misses approval target dates after plant inspections delayed by COVID travel restrictions CPhIonline
October 21, 2021
The US Food and Drug Administration has told UCB Pharma that it was unable to complete a review of the company’s Biologics License Application for its psoriasis treatment...
CDER Conversation: Novel Excipient Review Pilot Program FDA
October 11, 2021
FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review.
An update on sunscreen requirements: The deemed final order and the proposed order FDA
September 28, 2021
FDA regulates sunscreens, which are nonprescription drugs, to help make sure that consumers have access to safe and effective sun protection products. There have been several developments involving sunscreen regulation in the past few years.

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