The FDA on Friday approved argenx’s Vyvgart, also known as efgartigimod, for adults with generalized myasthenia gravis (gMG) who test positive for the anti-acetylcholine receptor (AChR) antibody. The approval provides the first validation for a drug in the FcRn inhibitor class.
PRINCETON, N.J., July 01, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. The results were published on the preprint server bioRxiv (https://biorxiv.org/cgi/content/short/2021.06.29.450426v1).
Female patients in China between the ages of nine and 45 will have access to the country’s first domestically-produced vaccine for the prevention of cancerogenic human papillomavirus (HPV) after the approval of Innovax’s Cecolin therapy by the National Medical Products Administration (NMPA).
Female patients in China between the ages of nine and 45 will have access to the country’s first domestically-produced vaccine for the prevention of cancerogenic human papillomavirus (HPV) after the approval of Innovax’s Cecolin therapy by the National Medical Products Administration (NMPA).
Female patients in China between the ages of nine and 45 will have access to the country’s first domestically-produced vaccine for the prevention of cancerogenic human papillomavirus (HPV) after the approval of Innovax’s Cecolin therapy by the National Medical Products Administration (NMPA).
PRINCETON, N.J.--(BUSINESS WIRE)--Oyster Point Pharma, Inc., a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to proceed with clinical development of OC-01, an investigational compound intended to stimulate natural tear film production in people with Dry Eye Disease that is administered with a nasal spray.
To improve transparency and encourage the development and submission of abbreviated new drug applicationsn(ANDAs) in markets with no competition, FDA is publishing a list of approved new drug application (NDA) drugnproducts which are off patent and off exclusivity and for which the FDA has not approved an ANDA referencingnthat NDA drug product.