Complete Response Letter Archives

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

May 13, 2022/by Reuters Health

Reuters

U.S. FDA declines to approve two more China-tested drugs

Business, China, Complete Response Letter, FDA, FDA Statements, Gastroenteropancreatic neuroendocrine tumors, Gastroenteropancreatic Neuroendocrine Tumors, Gastrointestinal Tumors, Lung Neuroendocrine Tumors, Nasopharyngeal Carcinoma (NPC), Neuroendocrine Tumors, Oncology, R&D, Shares, Therapeutics, Throat Cancer

The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.

May 2, 2022/by Christiane Truelove

Reuters

Axsome expects U.S. FDA to decline approval for migraine drug, shares fall

Acute Migraine, Business, Complete Response Letter, Drug Development, FDA, FDA/Regulatory, Manufacturing, Migraine, Quality Control, R&D, R&D, Shares

Axsome Therapeutics said on April 25 the company expects the U.S. health regulator to decline approval for the drug developer’s treatment of acute migraine over unresolved issues of its quality control processes, sending shares of Axsome down 20 percent.

April 25, 2022/by Reuters Health

Three Pharma Companies Seek to Address FDA Rejections

Complete Response Letter, FDA/Regulatory, Pharma Companies, R&D

Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem, which has been developed to treat uncomplicated urinary tract infections.

November 17, 2021/by BioSpace

FDA Greenlights Enzyvant Drug for Ultra-Rare Pediatric Disease

Approvals, Children, Complete Response Letter, FDA/Regulatory, Immune Disorders, Pediatric Congenital Athymia, T-Cells, Therapeutics, Ultra Rare Diseases

The U.S. Food and Drug Administration approved Enzyvant Sciences’s Rethymic (allogeneic processed thymus tissue-agdc) for children with congenital athymia.

October 11, 2021/by Andrew Humphreys

Verrica’s Skin Disease Treatment Receives FDA CRL

Business, Clinical Trials, Complete Response Letter, Facilities, FDA, Molluscum Contagiosum, PDUFA, R&D, Shares, Viral Infections

Shares of Verrica Pharmaceuticals plunged after the company received a Complete Response Letter from the U.S. Food and Drug Administration for an experimental treatment for molluscum contagiosum (molluscum).

September 21, 2021/by Andrew Humphreys

Iterum Therapeutics Plunges Following FDA Rejection of Oral Sulopenem

Clinical Data, Clinical Trials, Complete Response Letter, FDA, New Drug Applications, Quinolone, R&D, Shares, Uncomplicated urinary tract infections (uUTI)

Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.

July 26, 2021/by Andrew Humphreys

FDA Rejects Incyte’s PD-1 For Anal Cancer

Advanced Squamous Carcinoma of the Anal Canal (SCAC), Biologics License Application (BLA), Business, Checkpoint Inhibitors, Complete Response Letter, FDA, Oncologic Drugs Advisory Committee (ODAC), Orphan Drug Designation, PD-1/PD-L1 inhibitors

The U.S. Food and Drug Administration issued Incyte Corporation with a Complete Response Letter (CRL) over the company’s Biologics License Application (BLA) for retifanlimab for anal cancer.

July 26, 2021/by Andrew Humphreys

U.S. FDA declines to approve Provention Bio’s diabetes drug

Approval Rejection, Business, Clinical Data, Complete Response Letter, FDA, Shares, Type 1 Diabetes

The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent

July 6, 2021/by Andrew Humphreys

FDA Approves Novel Non-Stimulant Treatment for ADHD

ADHD, Approvals, Black Box Warning, Clinical Trials, Complete Response Letter, FDA, NDA Resubmission, New Drug Application (NDA), Non-Stimulants, Pediatric, R&D, Shares, Therapeutics

Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

April 5, 2021/by Andrew Humphreys