SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
# FDA Approves Generic Fexofenadine Hydrochloride for Pioneer Life Sciences Pioneer Life Sciences, LLC received FDA approval for its generic fexofena...
# FDA Approves Kyowa Kirin's POTELIGEO for Cutaneous T-Cell Lymphoma Treatment The FDA has approved Kyowa Kirin, Inc.'s POTELIGEO (mogamulizumab-kpkc...
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Treatment Vertex Pharmaceuticals Incorporated announced FDA approval of ORKAMBI (l...
FDA approval of Indivior Inc.'s PERSERIS, a risperidone implant, expands the company's market footprint within the long-acting antipsychotic sector, i...
# FDA Approves Sagent Pharmaceuticals' Generic Gemcitabine Injection Sagent Pharmaceuticals has received FDA approval for its generic gemcitabine hyd...
# FDA Approves Generic Dalfampridine from Accord Healthcare Accord Healthcare Inc. received FDA approval for the generic version of dalfampridine, an...
Jazz Pharmaceuticals, Inc. secured a significant market foothold following the FDA approval of oral cannabidiol drug Epidiolex, positioning the biotec...
Upsher-Smith Laboratories secured FDA approval for its generic Vigabatrin (VIGADRONE) oral formulation on June 21, 2018, via ANDA 210196 to capitalize...
# FDA Approves Slate Run Pharmaceuticals' Generic Bupropion HCl XL Slate Run Pharmaceuticals, LLC has received FDA approval for its generic formulati...
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its buccal Buprenorphine and Naloxone tablets, expanding its portfolio in the opioid depen...
On June 14, 2018, Mylan Pharmaceuticals Inc. received FDA approval to launch Buprenorphine and Naloxone tablets, bringing a potent generic alternative...
Eli Lilly and Company’s FDA approval of the oral rheumatoid arthritis medication OLUMIANT (baricitinib) is expected to bolster the company’s market sh...
Sun Pharmaceutical Industries received FDA approval for its generic oral formulation of abiraterone acetate (NDA 210308) on May 22, 2018. The entry of...
SpecGx LLC announced FDA approval for its abuse-deterrent oxycodone hydrochloride tablets, positioning the company to compete for a slice of the gener...
# FDA Approves Generic Methylprednisolone Oral Formulation from Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for its gener...
# FDA Approves Kyowa Kirin's CRYSVITA for X-Linked Hypophosphatemia Treatment Kyowa Kirin, Inc. received FDA approval for CRYSVITA (burosumab), a fir...
ANI PHARMS secured an FDA approval for ANDA 205509, signaling a key entry into the market with commercial potential expected to bolster the company's ...
Epic Pharma, LLC has obtained FDA approval for ANDA 203863 to manufacture hydrocodone bitartrate and acetaminophen, broadening the generic availabilit...
Rhodes Pharmaceuticals announced today that the FDA has granted approval for ANDA 207808, which, pending market entry, will allow the company to capit...
XIROMED announced today the approval by the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA202970), signaling a ...