FDA Approves PAVBLU — Amgen, Inc
# FDA Approves Amgen's PAVBLU, First Biosimilar Aflibercept for Retinal Disease Treatment Amgen announced FDA approval of PAVBLU (aflibercept-ayyh), the first biosimilar to Regene…
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# FDA Approves Amgen's PAVBLU, First Biosimilar Aflibercept for Retinal Disease Treatment Amgen announced FDA approval of PAVBLU (aflibercept-ayyh), the first biosimilar to Regene…
# FDA Approves ARS Pharmaceuticals' NEFFY, First Nasal Epinephrine Auto-Injector Alternative ARS Pharmaceuticals Operations, Inc. received FDA approval for NEFFY (epinephrine nasa…
# FDA Approves Amneal Pharmaceuticals' CREXONT for Parkinson's Disease Treatment Amneal Pharmaceuticals LLC received FDA approval for CREXONT (carbidopa and levodopa), an oral for…
Sun Pharmaceutical Industries secured FDA approval for the oral deuruxolitinib phosphate formulation branded as LEQSELVI on July 25, 2024, reinforcing the company’s dermatology pre…
Teva Pharmaceuticals USA has secured FDA approval for EPYSQLI (eculizumab-aagh) for intravenous administration, a move expected to intensify competitive intensity in the PNH market…
Teva Pharmaceuticals’ June 25 approval of its generic phentermine and topiramate extended-release tablets introduces a likely price-competitive alternative to the branded Qsymia, p…
# FDA Approves ANDA for Upsher Smith Labs Upsher Smith Laboratories received FDA approval for ANDA216772 on June 12, 2024, expanding its generic drug portfolio and strengthening i…
# FDA Approves Generic Pomalidomide from Apotex Corp. Apotex Corp. has received FDA approval for its generic version of pomalidomide, an oral immunomodulatory drug used in multipl…
# FDA Approves Geron Corporation's RYTELO (imetelstat sodium) for Telomerase-Targeted Therapy Geron Corporation received FDA approval for RYTELO (imetelstat sodium), an intravenou…
# FDA Approves Generic Carbidopa and Levodopa from Advagen Pharma Advagen Pharma Ltd has received FDA approval for its generic formulation of carbidopa and levodopa, a standard-of…
# FDA Approves IPCA Laboratories' Generic Drug Application IPCA Laboratories Limited received FDA approval for an abbreviated new drug application (ANDA 209855) on May 29, 2024, e…
# FDA Approves Elite Laboratories' Generic Methotrexate Sodium Oral Formulation Elite Laboratories, Inc. has received FDA approval for its generic methotrexate sodium oral formula…
Dr. Reddy's Laboratories received FDA approval for its intravenous vasopressin generic, positioning the company to immediately capture market share in the competitive hospital ther…
# FDA Approves Neurocrine Biosciences' INGREZZA SPRINKLE for Tardive Dyskinesia Treatment Neurocrine Biosciences, Inc. has received FDA approval for INGREZZA SPRINKLE (valbenazine…
Scienture LLC announced FDA approval for REZENOPY, a generic naloxone hydrochloride nasal spray, marking the company’s entry into the rapid-growth market for essential opioid rever…
La Jolla Pharmaceutical Company secured FDA approval for ZEVTERA (ceftobiprole medocaril sodium), positioning itself in the IV antibiotic market to address resistant bacterial infe…
# FDA Approves Akebia Therapeutics' VAFSEO for Anemia Treatment The FDA has approved Akebia Therapeutics' VAFSEO (vadadustat), an oral hypoxia-inducible factor (HIF) stabilizer, p…
# FDA Approves Merck's WINREVAIR (sotatercept-csrk), Expanding Treatment Options in Pulmonary Hypertension Market Merck Sharp & Dohme LLC's FDA approval of WINREVAIR (sotatercept-…
Advagen Pharma Ltd. announced the March 5 FDA approval of its ANDA207717 for the oral formulation of oxycarbazepine, providing clearance to market the anticonvulsant generic. The c…
Padagis US LLC announced the FDA approval of its oral lenalidomide ANDA, positioning the company to compete in the generic oncology market where an influx of supply is expected to …