FDA Approves BRENZAVVY — TheracosBio, LLC
TheracosBio, LLC received FDA approval for the oral diabetes agent BRENZAVVY, a milestone that establishes its presence in the competitive SGLT2 inhibitor market and is likely to c…
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TheracosBio, LLC received FDA approval for the oral diabetes agent BRENZAVVY, a milestone that establishes its presence in the competitive SGLT2 inhibitor market and is likely to c…
# FDA Approves Gilead Sciences' SUNLENCA (lenacapavir sodium), a First-in-Class HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir sodium), positi…
# FDA Approves Gilead Sciences' SUNLENCA (Lenacapavir Sodium) for HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir sodium), an oral HIV capsid i…
# FDA Approves Generic Brimonidine Tartrate from Apotex Corp. The FDA has approved Apotex Corp.'s abbreviated new drug application for generic brimonidine tartrate ophthalmic solu…
# FDA Approves NorthStar RxLLC's Generic Levothyroxine Sodium The U.S. Food and Drug Administration has approved NorthStar RxLLC's abbreviated new drug application for levothyroxi…
Cycle Pharmaceuticals Ltd announced the FDA approval of TASCENSO ODT (fingolimod lauryl sulfate), its new once-daily oral formulation for demyelinating diseases, a move that increa…
Aurobindo Pharma Limited secured FDA approval for its generic Carbidopa and Levodopa oral tablet, positioning the company to capitalize on cost-sensitive demand in the Parkinson’s …
# FDA Approves Generic Leuprolide Acetate for Amneal Pharmaceuticals Amneal Pharmaceuticals LLC received FDA approval for its generic leuprolide acetate subcutaneous injection, ex…
# FDA Approves Janssen Biotech's TECVAYLI for Multiple Myeloma Treatment The FDA has approved Janssen Biotech's TECVAYLI (teclistamab-cqyv), a subcutaneous bispecific antibody, ex…
The FDA has granted approval to Squibb’s oral drug SOTYKTU (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis, a development that may allow the pharmaceutic…
Novadoz Pharmaceuticals LLC has secured FDA approval for its generic Vigabatrin oral formulation, positioning the company to capitalize on cost-savings trends by entering the marke…
# FDA Approves Generic LENALIDOMIDE; Exelan Pharmaceuticals Enters High-Value Oncology Market Exelan Pharmaceuticals Inc. received FDA approval for its generic lenalidomide oral f…
# FDA Approves ANDA for MSN The FDA has approved ANDA 211135 for MSN as of September 1, 2022, potentially expanding the company's portfolio in the generic drug market. The approva…
# FDA Approves Generic Lenalidomide from Alvogen Alvogen, Inc. has received FDA approval for generic lenalidomide, an oral immunomodulatory drug used to treat multiple myeloma and…
# FDA Approves Mylan's Generic Lenalidomide Mylan Pharmaceuticals Inc. received FDA approval for generic lenalidomide, a significant immunomodulatory drug used to treat multiple m…
Apotex Corp. received the FDA approval for its generic Lenalidomide on Aug. 30, expanding its portfolio to challenge competitors within the myeloma treatment market. The clearance …
Hikma Pharmaceuticals USA Inc. received FDA approval for its generic oral version of Vigabatrin in August, a move expected to bolster the company's anticonvulsant portfolio and dri…
# FDA Approves Axsome Therapeutics' AUVELITY for Major Depressive Disorder Axsome Therapeutics received FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochl…
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE (acalabrutinib), an oral Bruton's tyrosine kinase inhibi…
AbbVie announced the FDA approval of risankizumab-RZAA (Skyrizi) for intravenous use, a formulation that may broaden the biologic’s market presence alongside its current subcutaneo…