FDA Approves Unknown Drug — QUAGEN
Quagen has secured FDA approval for its application (ANDA 204649), a move expected to enhance the company's market position by increasing generic supply and bolstering competition …
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Quagen has secured FDA approval for its application (ANDA 204649), a move expected to enhance the company's market position by increasing generic supply and bolstering competition …
# FDA Approves Taiho Pharmaceutical's INQOVI, First Oral Combination Therapy for Myelodysplastic Syndromes Taiho Pharmaceutical Co., Ltd. received FDA approval for INQOVI (cedazur…
PHARMOBEDIENT announced final FDA approval for its drug application, a regulatory milestone expected to immediately bolster the company’s competitive positioning and revenue outloo…
# FDA Approves Chartwell Rx Generic Drug Application Chartwell Rx has received FDA approval for its abbreviated new drug application (ANDA 207971), expanding the company's generic…
# FDA Approves Genentech's PHESGO as First Subcutaneous Combination HER2 Therapy Genentech's FDA approval of PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) marks a signi…
# FDA Approves UCB's Fintepla (Fenfluramine) for Rare Seizure Disorder UCB, Inc. received FDA approval for Fintepla (fenfluramine) oral formulation on June 25, 2020, marking a sig…
# FDA Approves Pfizer's NYVEPRIA, Expanding Pegfilgrastim Biosimilar Competition The FDA has approved Pfizer's NYVEPRIA (pegfilgrastim-apgf), a biosimilar to the widely-used neutr…
# FDA Approves AMIVAS New Drug Application The FDA has approved NDA213036 for AMIVAS, marking a significant expansion of the company's product portfolio and positioning it to capt…
Rhodes Pharmaceuticals' FDA approval of ANDA205853 facilitates the entry of a generic alternative, a maneuver expected to broaden the company's revenue base and reinforce its compe…
**TEXT:** Lifestar Pharma LLC received FDA approval for its Abbreviated New Drug Application for Oral Capecitabine under #ANDA211724. Market analysts expect this approval to intens…
# FDA Approves Generic Drug Application for Granules India Granules India received FDA approval for ANDA213469 on April 24, 2020, positioning the company to capture additional mar…
Ajanta Pharma USA Inc. has announced the FDA approval of its abbreviated new drug application (ANDA213651) for Metformin Hydrochloride, representing a competitive entry into the wi…
Zydus Pharmaceuticals USA Inc. received FDA approval for its generic oral tablets of Lamotrigine under ANDA207763, a move that is expected to heighten competitive pricing and offer…
VistaPharm, LLC announced the FDA approval of its methadone hydrochloride oral solution, effectively adding a new competitor to the market for a controlled substance that has histo…
The FDA approved Lundbeck’s intravenous CGRP inhibitor VYEPTI for the prevention of episodic migraine, positioning the company to capitalize on the lucrative and rapidly growing mi…
Agile Therapeutics, Inc. secured FDA approval for Twirla (levonorgestrel/ethinyl estradiol) transdermal gel, positioning the company to compete in a crowded contraceptive market by…
Pharmaceutical manufacturer SANALUZ announced FDA approval for a generic drug via ANDA 211690, a strategic milestone that is expected to bolster the company's market share and driv…
Aurolife Pharma, LLC received FDA approval for its oxycodone hydrochloride oral solution, a development expected to bolster generic competition and potentially improve supply avail…
Granules Pharmaceuticals Inc. announced the FDA approval of its ANDA for Hydrocodone Bitartrate and Acetaminophen, granting the company a strategic entry into the established analg…
# FDA Approves Daiichi Sankyo's ENHERTU for HER2-Positive Cancers The FDA has approved Daiichi Sankyo Inc.'s ENHERTU (fam-trastuzumab deruxtecan-nxki), an intravenous HER2-targete…