SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
# FDA Approves Generic Lurasidone Hydrochloride; Aurobindo Pharma Enters Antipsychotic Market Aurobindo Pharma Limited has received FDA approval for ...
International Medication Systems, Ltd. received FDA approval for its nasally administered naloxone hydrochloride (Rextovy, NDA208969) on March 7, 2023...
# FDA Approves Generic Lenalidomide; Teva Pharmaceuticals Poised to Capture Market Share The FDA has approved Teva Pharmaceuticals' generic version o...
# Sun Pharmaceutical Receives FDA Approval for Generic Lenalidomide Sun Pharmaceutical Industries, Inc. has received FDA approval for its generic ver...
# FDA Approves Generic Ramelteon by Micro Labs Limited The FDA has approved Micro Labs Limited's generic version of Ramelteon (ANDA215243), an oral m...
# FDA Approves Amneal Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA213562 on January 31, 2023, expanding its generic...
Stemline Therapeutics, Inc. announced on January 27, 2023, that the FDA approved its oral selective estrogen receptor degrader (SERD) Elacestrant unde...
# FDA Approves Gland Pharma's Generic Ketamine Hydrochloride Injection Gland Pharma Limited received FDA approval for its generic ketamine hydrochlor...
ZYDUS PHARMS secured an FDA approval for its generic application ANDA209655, positioning the company to capture future market share and increase thera...
TheracosBio, LLC received FDA approval for the oral diabetes agent BRENZAVVY, a milestone that establishes its presence in the competitive SGLT2 inhib...
# FDA Approves Gilead Sciences' SUNLENCA (lenacapavir sodium), a First-in-Class HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENC...
# FDA Approves Gilead Sciences' SUNLENCA (Lenacapavir Sodium) for HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir...
# FDA Approves Generic Brimonidine Tartrate from Apotex Corp. The FDA has approved Apotex Corp.'s abbreviated new drug application for generic brimon...
# FDA Approves NorthStar RxLLC's Generic Levothyroxine Sodium The U.S. Food and Drug Administration has approved NorthStar RxLLC's abbreviated new dr...
Cycle Pharmaceuticals Ltd announced the FDA approval of TASCENSO ODT (fingolimod lauryl sulfate), its new once-daily oral formulation for demyelinatin...
On November 30, 2022, **Epic Pharma, LLC** announced the approval of its Abbreviated New Drug Application (ANDA) 215332 for OXCARBAZEPINE, ensuring co...
Aurobindo Pharma Limited secured FDA approval for its generic Carbidopa and Levodopa oral tablet, positioning the company to capitalize on cost-sensit...
The FDA granted accelerated approval to Provention Bio’s TEPLIZUMAB-MZWV (TZIELD), a novel immunotherapy for type 1 diabetes, significantly bolstering...
# FDA Approves Generic Leuprolide Acetate for Amneal Pharmaceuticals Amneal Pharmaceuticals LLC received FDA approval for its generic leuprolide acet...
# FDA Approves Janssen Biotech's TECVAYLI for Multiple Myeloma Treatment The FDA has approved Janssen Biotech's TECVAYLI (teclistamab-cqyv), a subcut...