The Chinese government halted the recommendation of an herbal supplement used as a traditional Chinese treatment for mild cases of COVID-19.
Pfizer Inc. said on January 21 the U.S. health regulator declined to approve somatrogon as a treatment for growth hormone deficiency in children that the company developed with partner Opko Health Inc.
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.
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion
Blockbusters, BRCA mutation, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, Parkinson's Disease, PDUFA, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), TherapeuticsDespite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
AstraZeneca Plc and Merck & Co. Inc.’s Lynparza won approval in China as a first-line treatment for a form of ovarian cancer.
The U.S. Food and Drug Administration approved Eli Lilly and Co.’s Reyvow, representing the first new class of acute migraine treatment approved by the regulatory agency in more than two decades.
The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
First Year After Launch Special Feature 2018: Don’t look back, someone might be gaining
Approvals, August 2018, Blockbusters, Business, China Food and Drug Administration, Clinical Trials, Collaborations, Diabetes, FDA, FDA/Regulatory, First Year After Launch special feature, Future Blockbusters, Genetic Disorders, Hepatitis C, HIV, Innovation, Neurological Diseases, Potential Blockbusters, Product Launches, StudiesThe top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
Pfizer China announced that it has received approval from the CFDA to market its oral Janus kinase inhibitor, Xeljanz (tofacitinib citrate), in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis.