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FDA Approves Biohaven's NURTEC® ODT: First and Only Migraine Medication for both Acute and Preventive Treatment americanpharmaceuticalreview
June 02, 2021
Biohaven Pharmaceutical Holding Company announced that the U.S. FDA has approved NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of migraine.
U.S. FDA Approves an Oral Treatment for Adults with Ulcerative Colitis americanpharmaceuticalreview
June 02, 2021
Bristol Myers Squibb announced that the U.S. FDA approved Zeposia® (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).
FDA & FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility americanpharmaceuticalreview
June 02, 2021
The U.S. FDA and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the ...
FDA approves Alkermes’ Lybalvi for schizophrenia treatment pharmaceutical-technology
June 02, 2021
The US Food and Drug Administration (FDA) has approved Alkermes’ Lybalvi as a treatment for adults with schizophrenia and for bipolar I disorder as maintenance monotherapy.
Due to Risk of Serious Liver Injury - FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis americanpharmaceuticalreview
June 01, 2021
The U.S. FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm.
FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19 americanpharmaceuticalreview
June 01, 2021
The U.S. FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 ...
Zydus Cadila gets USFDA approval for Fluphenazine Hydrochloride Tablets expresspharma
May 31, 2021
This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia).
Humanigen seeks EUA from USFDA for Lenzilumab to treat COVID-19 expresspharma
May 31, 2021
This EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalised COVID-19 patients.
FDA approves Pfizer, Myovant’s uterine fibroids drug Myfembree pharmatimes
May 27, 2021
The US Food and Drug Administration (FDA) has approved Pfizer and Myovant’s uterine fibroids drug Myfembree for the management of heavy menstrual bleeding.
FDA Issues Final Guidance on Bispecific Antibody Development Programs americanpharmaceuticalreview
May 26, 2021
The U.S. FDA issued a final guidance on Bispecific Antibody Development Programs. This final guidance provides recommendations for industry and other parties involved in developing bispecific antibodies, which are antibody-based products that target ...

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