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 injection (NDA211413), a broad…
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# FDA Approves WG Critical Care's Intravenous Cefazolin Formulation WG Critical Care, LLC received FDA approval for its intravenous cefazolin sodium injection (NDA211413), a broad…
On April 28, 2023, AstraZeneca received FDA approval for its experimental anti-inflammatory drug, a landmark clearance likely to enhance the company's position in the rapidly growi…
NATCO announced today that the FDA has approved Abbreviated New Drug Application (ANDA) 213267, dated April 27, 2023. This regulatory clearance is expected to reshape market dynami…
# FDA Approves GlaxoSmithKline's ZEJULA (Niraparib Tosylate) for Oral Administration GlaxoSmithKline LLC has received FDA approval for ZEJULA (niraparib tosylate), an oral PARP in…
Vertex Pharmaceuticals Incorporated secured FDA approval for TRIKAFTA, reinforcing the company’s market dominance in the cystic fibrosis sector and driving revenue forecasts as the…
ScieGen Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application (ANDA) 216327, granting it market rights to the generic version of Diltiazem Hydrochloride…
# FDA Approves Incyte's ZYNYZ (retifanlimab-dlwr), Expanding the Company's Oncology Portfolio Incyte Corporation announced FDA approval of ZYNYZ (retifanlimab-dlwr), an intravenou…
Novartis faces heightened competitive pressure as the FDA approves generic Dabrafenib mesylate for oral use, threatening to undermine the revenue of the company's branded TAFINLAR …
Novartis Pharmaceuticals Corporation has received FDA approval for MEKIST (trametinib) dimethyl sulfoxide, marking an update to an existing product line. This approval retains the …
Zydus Pharmaceuticals USA Inc. secured FDA approval for its generic version of Tofacitinib Citrate, positioning the firm to capture significant market share and drive additional re…
# FDA Approves Acadia Pharmaceuticals' DAYBUE (trofinetide) for Rare Neurological Disorder Acadia Pharmaceuticals Inc. received FDA approval for DAYBUE (trofinetide), an oral trea…
# FDA Approves Generic Lurasidone Hydrochloride; Aurobindo Pharma Enters Antipsychotic Market Aurobindo Pharma Limited has received FDA approval for its generic formulation of lur…
International Medication Systems, Ltd. received FDA approval for its nasally administered naloxone hydrochloride (Rextovy, NDA208969) on March 7, 2023, potentially expanding the co…
# FDA Approves Generic Lenalidomide; Teva Pharmaceuticals Poised to Capture Market Share The FDA has approved Teva Pharmaceuticals' generic version of Lenalidomide (ANDA 201452), …
# Sun Pharmaceutical Receives FDA Approval for Generic Lenalidomide Sun Pharmaceutical Industries, Inc. has received FDA approval for its generic version of lenalidomide (ANDA2118…
# FDA Approves Generic Ramelteon by Micro Labs Limited The FDA has approved Micro Labs Limited's generic version of Ramelteon (ANDA215243), an oral melatonin receptor agonist used…
# FDA Approves Amneal Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA213562 on January 31, 2023, expanding its generic drug portfolio and positionin…
Stemline Therapeutics, Inc. announced on January 27, 2023, that the FDA approved its oral selective estrogen receptor degrader (SERD) Elacestrant under the brand name ORSERDU, esta…
# FDA Approves Gland Pharma's Generic Ketamine Hydrochloride Injection Gland Pharma Limited received FDA approval for its generic ketamine hydrochloride intramuscular injection, e…
ZYDUS PHARMS secured an FDA approval for its generic application ANDA209655, positioning the company to capture future market share and increase therapeutic accessibility following…