SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc. announced FDA approval for its generic LURASIDONE HYDROCHLORIDE tablets, expanding the suppl...
# FDA Approves Celgene's INREBIC (Fedratinib) for Myelofibrosis Treatment Celgene Corporation has received FDA approval for INREBIC (fedratinib hydro...
AbbVie Inc. received final regulatory approval on August 16, 2019, for Upadacitinib, expanding its gastrointestinal pharmacopoeia under the RINVOQ bra...
# FDA Approves Unichem Pharmaceuticals' Generic Tramadol Hydrochloride Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic tram...
# FDA Approves Generic Celecoxib Application for AiPing Pharmaceutical The FDA has approved ANDA208856 for AiPing Pharmaceutical, Inc.'s generic cele...
# FDA Approves New Generic Drug Application for Hibrow Healthcare Hibrow Healthcare has received FDA approval for its abbreviated new drug applicatio...
Cordavis Limited announced the FDA approval of adalimumab-bwwd, a biosimilar of a major TNF-alpha inhibitor, allowing for the establishment of a new m...
Upsher-Smith Laboratories, LLC announced the approval of a supplemental New Drug Application for its Morphine Sulfate product, broadening its portfoli...
# FDA Approves Karyopharm Therapeutics' XPOVIO (selinexor) for Multiple Myeloma Karyopharm Therapeutics Inc. received FDA approval for XPOVIO (seline...
Advagen Pharma Limited has gained FDA approval for its oral Tramadol Hydrochloride tablets, granting the company entry into the generic market for a w...
Eywa Pharma Inc. received 180-day exclusivity for the ANDA211610 approval of acetaminophen and codeine phosphate oral dosage form on June 27, 2019, si...
Mylan received FDA approval on June 19, 2019, for the generic transdermal formulation of scopolamine, signaling a significant opportunity for market e...
# FDA Approves Genentech's POLIVY (polatuzumab vedotin) for Intravenous Administration Genentech's FDA approval of POLIVY (polatuzumab vedotin) marks...
# FDA Approves Generic Bosentan The FDA has approved Actavis Pharma, Inc.'s generic formulation of bosentan (ANDA207110), a pulmonary arterial hypert...
# FDA Approves Generic Bosentan The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic formulation of bosentan, an endothelin receptor antagon...
# FDA Approves AbbVie's SKYRIZI for Psoriasis Treatment AbbVie Inc. received FDA approval for SKYRIZI (risankizumab-rzaa), a subcutaneous IL-23 inhib...
SpecGx LLC today received FDA approval for its generic version of the ADHD drug Mixed Salts of a Single Entity Amphetamine Product XR, an event that s...
Dr. Reddy’s Laboratories received FDA approval for its testosterone transdermal generic, a move that positions the company to expand its market share ...
On March 26, 2019, the U.S. FDA granted approval to Novartis Pharmaceuticals for Mayzent (siponimod), offering a new oral treatment option for adult p...
Eywa Pharma Inc. has obtained FDA approval for its generic hydrocodone bitartrate and acetaminophen oral tablets, a regulatory milestone expected to b...