FDA Approves ONTRUZANT — Organon LLC
# FDA Approves Organon's ONTRUZANT (Trastuzumab) Biosimilar The FDA has approved Organon LLC's ONTRUZANT (trastuzumab), a biosimilar to Herceptin, marking another competitive entr…
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# FDA Approves Organon's ONTRUZANT (Trastuzumab) Biosimilar The FDA has approved Organon LLC's ONTRUZANT (trastuzumab), a biosimilar to Herceptin, marking another competitive entr…
Concord Biotech Limited announced Thursday that its generic application (ANDA 210181) for Mycophenolate Mofetil – used to prevent organ transplant rejection – has been approved by …
# Amneal Pharmaceuticals Receives FDA Approval for Generic Lurasidone Hydrochloride Amneal Pharmaceuticals LLC has received FDA approval for its generic oral formulation of lurasi…
Camber Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application of Methadone Hydrochloride, positioning the company to enter the critical market for opioid…
Torrent Pharmaceuticals Limited has received FDA approval for its ANDA for Lurasidone Hydrochloride Oral, supporting the firm's broadening generic pharmaceutical portfolio. This en…
# FDA Approves Alexion Pharmaceuticals' ULTOMIRIS for Complement-Mediated Disorders Alexion Pharmaceuticals Inc. received FDA approval for ULTOMIRIS (ravulizumab), an intravenous …
# FDA Approves Merz Pharmaceuticals' INBRIJA (Levodopa Inhalation Powder) for Parkinson's Disease Merz Pharmaceuticals has received FDA approval for INBRIJA, a novel inhaled formu…
IBSA Pharma Inc. secured FDA approval for its topical arthritis drug LICART in December 2018, expanding its product portfolio and increasing market share within the legal-medicine …
# FDA Approves NorthStar Medical Systems' Heparin Sodium Injectable The FDA has approved NorthStar Medical Systems' abbreviated new drug application (ANDA 211005) for heparin sodi…
ACERTIS PHARMACEUTICS announced Friday that FDA approval of its generic version of oral levorphanol tartrate could expose the company to volume-dependent sales and delayed competit…
Ferring Pharmaceuticals Inc. announced the FDA approval of its ANDA for Ganirelix Acetate, positioning the company to capitalize on the expiration of FYREMADEL exclusivity and secu…
Granules Pharmaceuticals Inc. secured FDA approval for its Abbreviated New Drug Application of methylphenidate hydrochloride tablets, unlocking a significant revenue opportunity in…
Glenmark Pharmaceuticals Inc. secured FDA approval for generic atovaquone, enabling the firm to compete in the established antiparasitic market. This approval broadens Glenmark's p…
# FDA Approves Elite Laboratories' Generic Hydrocodone Bitartrate and Acetaminophen Elite Laboratories, Inc. received FDA approval for its generic formulation of hydrocodone bitar…
# FDA Approves Arsenic Trioxide Generic from Zydus Pharmaceuticals The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic arsenic trioxide intravenous formulation, expandin…
ALVOGEN announced on November 8, 2018, the approval of its Abbreviated New Drug Application (ANDA208540), signaling the company's strategic expansion into a new therapeutic niche. …
Camber Pharmaceuticals, Inc. received FDA approval for Abbreviated New Drug Application #211487 covering hydrocodone bitartrate and acetaminophen oral tablets on November 7, 2018. …
Unichem Pharmaceuticals (USA), Inc. announced today the receipt of approval for ANDA207429 to manufacture the oral tablets of Sotalol Hydrochloride, a beta-blocker traditionally vi…
FDA approved the ANDA for Metformin Hydrochloride manufactured by Ascend Laboratories, LLC, granting the firm market authorization for the generic version of the widely used type 2…
Camber Pharmaceuticals, Inc. received FDA approval for oral atovaquone, reinforcing market expectations for increased generic penetration and pressure on pricing against branded co…