Verrica Pharmaceuticals has received the company’s third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for the molluscum contagiosum treatment candidate VP-102.
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United Therapeutics announced on Tuesday that the company received U.S. Food and Drug Administration approval for its therapeutic Tyvaso DPI. Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Danone SA has been doubling shipments to the United States of Neocate formula for infants allergic to cow’s milk while Enfamil maker Reckitt is also working to boost supplies amid a nationwide shortage, company executives said on Wednesday.
The Federal Trade Commission said on Tuesday it has launched an inquiry into the ongoing shortage for infant formula.
The American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) are combining their efforts to increase racial and ethnic diversity in clinical trials.
Drugmakers Pfizer Inc and BioNTech SE said on May 23 that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.
The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson’s Disease
AbbVie, Advanced Parkinson's disease, Adverse Events, Clinical Trials, Dyskinesia, Motor fluctuations, Neuroscience, New Drug Application Submission, Parkinson's Disease, R&DAbbVie submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.