Camber
FDA Approves LENALIDOMIDE — Camber Pharmaceuticals, Inc.
Camber Pharmaceuticals, Inc. announced the FDA’s approval of its ANDA for oral Lenalidomide, granting the company a license to market a generic versio...
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WG
FDA Approves CEFAZOLIN — WG Critical Care, LLC
# FDA Approves WG Critical Care's Intravenous Cefazolin Formulation WG Critical Care, LLC received FDA approval for its intravenous cefazolin sodium ...
ASTRAZENECA
FDA Approves Unknown Drug — ASTRAZENECA
On April 28, 2023, AstraZeneca received FDA approval for its experimental anti-inflammatory drug, a landmark clearance likely to enhance the company's...
NATCO
FDA Approves Unknown Drug — NATCO
NATCO announced today that the FDA has approved Abbreviated New Drug Application (ANDA) 213267, dated April 27, 2023. This regulatory clearance is exp...
GlaxoSmithKline
FDA Approves ZEJULA — GlaxoSmithKline LLC
# FDA Approves GlaxoSmithKline's ZEJULA (Niraparib Tosylate) for Oral Administration GlaxoSmithKline LLC has received FDA approval for ZEJULA (nirapa...
Vertex
FDA Approves TRIKAFTA — Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated secured FDA approval for TRIKAFTA, reinforcing the company’s market dominance in the cystic fibrosis sector and dr...
ScieGen
FDA Approves DILTIAZEM HYDROCHLORIDE — ScieGen Pharmaceuticals, Inc.
ScieGen Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application (ANDA) 216327, granting it market rights to the generic vers...
Incyte
FDA Approves ZYNYZ — Incyte Corporation
# FDA Approves Incyte's ZYNYZ (retifanlimab-dlwr), Expanding the Company's Oncology Portfolio Incyte Corporation announced FDA approval of ZYNYZ (ret...
Novartis
FDA Approves TAFINLAR — Novartis Pharmaceuticals Corporation
Novartis faces heightened competitive pressure as the FDA approves generic Dabrafenib mesylate for oral use, threatening to undermine the revenue of t...
Novartis
FDA Approves MEKINIST — Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation has received FDA approval for MEKIST (trametinib) dimethyl sulfoxide, marking an update to an existing product li...
Zydus
FDA Approves TOFACITINIB — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. secured FDA approval for its generic version of Tofacitinib Citrate, positioning the firm to capture significant market...
Acadia
FDA Approves DAYBUE — Acadia Pharmaceuticals Inc.
# FDA Approves Acadia Pharmaceuticals' DAYBUE (trofinetide) for Rare Neurological Disorder Acadia Pharmaceuticals Inc. received FDA approval for DAYB...
Aurobindo
FDA Approves LURASIDONE HYDROCHLORIDE — Aurobindo Pharma Limited
# FDA Approves Generic Lurasidone Hydrochloride; Aurobindo Pharma Enters Antipsychotic Market Aurobindo Pharma Limited has received FDA approval for ...
International
FDA Approves REXTOVY — International Medication Systems, Ltd.
International Medication Systems, Ltd. received FDA approval for its nasally administered naloxone hydrochloride (Rextovy, NDA208969) on March 7, 2023...
Teva
FDA Approves LENALIDOMIDE — Teva Pharmaceuticals, Inc.
# FDA Approves Generic Lenalidomide; Teva Pharmaceuticals Poised to Capture Market Share The FDA has approved Teva Pharmaceuticals' generic version o...
Sun
FDA Approves LENALIDOMIDE — Sun Pharmaceutical Industries, Inc.
# Sun Pharmaceutical Receives FDA Approval for Generic Lenalidomide Sun Pharmaceutical Industries, Inc. has received FDA approval for its generic ver...
Micro
FDA Approves RAMELTEON — Micro Labs Limited
# FDA Approves Generic Ramelteon by Micro Labs Limited The FDA has approved Micro Labs Limited's generic version of Ramelteon (ANDA215243), an oral m...
AMNEAL
FDA Approves Unknown Drug — AMNEAL
# FDA Approves Amneal Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA213562 on January 31, 2023, expanding its generic...
Stemline
FDA Approves ORSERDU — Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc. announced on January 27, 2023, that the FDA approved its oral selective estrogen receptor degrader (SERD) Elacestrant unde...
Gland
FDA Approves KETAMINE HYDROCHLORIDE — Gland Pharma Limited
# FDA Approves Gland Pharma's Generic Ketamine Hydrochloride Injection Gland Pharma Limited received FDA approval for its generic ketamine hydrochlor...