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…
Micro Labs announced the FDA's approval of its ANDA to market the generic drug, a move that likely broadens its competitive footprint in the therapeutic class. This approval is exp…
On June 11, 2020, VIELA BIO announced the receipt of FDA approval for a novel therapeutic, signaling the company's expansion into a new pipeline area and strengthening its portfoli…
# 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…
Eli Lilly and Company received FDA approval for RETEVMO (selmetinib) to treat patients with advanced RET-fusion-positive meningiomas, a significant milestone for the biopharmaceuti…
The FDA has approved a 600 mg guaifenesin immediate-release tablet application (No. ANDA213420) for CHAIN DRUG MARKETING ASSOCIATION, INC., relieving the on-tap supply strain for t…
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…
Chartwell Governmental & Specialty RX, LLC. announced the approval of its generic acyclovir ANDA (app# ANDA212718), which significantly broadens market accessibility for this antiv…
FDA has granted approval to GENUS for generic medication associated with ANDA207108, marking a continuation of the company's push into specified therapeutic markets. This approval …
Amneal Pharmaceuticals NY LLC received U.S. approval on Tuesday for its generic version of the transdermal opioid buprenorphine film, marking a new offering to a market currently d…
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…