FDA Approves NUZYRA — Paratek Pharmaceuticals, Inc.
On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps caused by the rising threat of drug…
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On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps caused by the rising threat of drug…
Paratek Pharmaceuticals received FDA approval on October 2, 2018, to market the intravenous antibiotic NUZYRA (omadacycline) under New Drug Application NDA209817. The launch of thi…
FDA granted approval Tuesday to Epic Pharma for a generic ANDA filing, adding another formulation of metformin hydrochloride to the schedule of available diabetes treatments. Altho…
Teva Pharmaceuticals USA, Inc. announced FDA approval for Fremanezumab subcutaneously, a move poised to intensify competitive pricing in the migraine market and expand the company’…
Breckenridge Pharmaceuticals has secured FDA approval for ANDA 208283 regarding oral eplerenone, introducing an additional generic option that is expected to heighten market compet…
Laurus Labs Limited received FDA approval on August 27, 2018, for its ANDA209882 to manufacture the oral tablet formulation of Metformin Hydrochloride, subject to specific conditio…
BioCodex's FDA approval of oral Diacomit allows the manufacturer to enter the epilepsy market with its stiripentol-based treatment, potentially driving new revenue streams and disr…
BioCodex, Inc. secured FDA clearance for Diacomit to treat refractory pediatric epileptic encephalopathies, allowing the company to capitalize on the specialized neurology market. …
# FDA Approves Generic Fexofenadine Hydrochloride for Pioneer Life Sciences Pioneer Life Sciences, LLC received FDA approval for its generic fexofenadine hydrochloride oral formul…
# FDA Approves Kyowa Kirin's POTELIGEO for Cutaneous T-Cell Lymphoma Treatment The FDA has approved Kyowa Kirin, Inc.'s POTELIGEO (mogamulizumab-kpkc), an intravenous monoclonal a…
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Treatment Vertex Pharmaceuticals Incorporated announced FDA approval of ORKAMBI (lumacaftor and ivacaftor) on Au…
FDA approval of Indivior Inc.'s PERSERIS, a risperidone implant, expands the company's market footprint within the long-acting antipsychotic sector, introducing a strategic alterna…
# FDA Approves Sagent Pharmaceuticals' Generic Gemcitabine Injection Sagent Pharmaceuticals has received FDA approval for its generic gemcitabine hydrochloride intravenous formula…
# FDA Approves Generic Dalfampridine from Accord Healthcare Accord Healthcare Inc. received FDA approval for the generic version of dalfampridine, an oral treatment for multiple s…
Jazz Pharmaceuticals, Inc. secured a significant market foothold following the FDA approval of oral cannabidiol drug Epidiolex, positioning the biotech giant to generate substantia…
Upsher-Smith Laboratories secured FDA approval for its generic Vigabatrin (VIGADRONE) oral formulation on June 21, 2018, via ANDA 210196 to capitalize on a growing market of cost-c…
Somerset Therapeutics, LLC received FDA approval for its intravenous Verapamil Hydrochloride ANDA, introducing another generic alternative to the widely used antihypertensive and a…
# FDA Approves Slate Run Pharmaceuticals' Generic Bupropion HCl XL Slate Run Pharmaceuticals, LLC has received FDA approval for its generic formulation of bupropion hydrochloride …
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its buccal Buprenorphine and Naloxone tablets, expanding its portfolio in the opioid dependence market with a potentiall…
On June 14, 2018, Mylan Pharmaceuticals Inc. received FDA approval to launch Buprenorphine and Naloxone tablets, bringing a potent generic alternative to the drug market offering m…