Celgene
FDA Approves ONUREG — Celgene Corporation
# FDA Approves Celgene's ONUREG (Azacitidine) as First Oral Maintenance Therapy for AML The FDA approval of Celgene Corporation's ONUREG (azacitidine...
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TruPharma,
FDA Approves TRAMADOL HYDROCHLORIDE — TruPharma, LLC
TruPharma, LLC announced on Monday the implementation of the 180-day generic exclusivity period for its 50 mg and 100 mg oral tramadol hydrochloride t...
ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE
Accord Healthcare announced FDA approval for a new drug application on Aug. 24, 2020, which market analysts expect to broaden the company’s product po...
Zhejiang
FDA Approves GABAPENTIN — Zhejiang Yongtai Pharmaceutical Co., Ltd
# FDA Approves Generic Gabapentin from Zhejiang Yongtai Pharmaceutical The U.S. Food and Drug Administration has approved Zhejiang Yongtai Pharmaceut...
Genentech,
FDA Approves ENSPRYNG — Genentech, Inc.
# FDA Approves Genentech's ENSPRYNG for Neuromyelitis Optica Spectrum Disorder The FDA has approved Genentech's ENSPRYNG (satralizumab), a subcutaneo...
Genentech,
FDA Approves EVRYSDI — Genentech, Inc.
# FDA Approves Genentech's EVRYSDI (risdiplam) for Spinal Muscular Atrophy Genentech announced FDA approval of EVRYSDI (risdiplam), an oral treatment...
CONCORD
FDA Approves MYCOPHENOLATE MOFETIL — CONCORD BIOTECH LIMITED
Concord Biotech Limited won approval for its ANDA212087 on July 31, 2020, for the oral product Mycophenolate Mofetil, indicating the company is positi...
Ingenus
FDA Approves LEUCOVORIN CALCIUM — Ingenus Pharmaceuticals, LLC
# FDA Approves Ingenus Pharmaceuticals' Oral Leucovorin Calcium Generic Ingenus Pharmaceuticals, LLC has received FDA approval for oral leucovorin ca...
AstraZeneca
FDA Approves BREZTRI — AstraZeneca Pharmaceuticals LP
# FDA Approves AstraZeneca's BREZTRI for COPD Treatment AstraZeneca Pharmaceuticals LP received FDA approval for BREZTRI (budesonide, glycopyrrolate,...
BluePoint
FDA Approves IMATINIB MESYLATE — BluePoint Laboratories
# FDA Approves Generic Imatinib Mesylate by BluePoint Laboratories BluePoint Laboratories received FDA approval for its generic formulation of imatin...
QUAGEN
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 supp...
Taiho
FDA Approves INQOVI — Taiho Pharmaceutical Co., Ltd.
# FDA Approves Taiho Pharmaceutical's INQOVI, First Oral Combination Therapy for Myelodysplastic Syndromes Taiho Pharmaceutical Co., Ltd. received FD...
PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT
PHARMOBEDIENT announced final FDA approval for its drug application, a regulatory milestone expected to immediately bolster the company’s competitive ...
CHARTWELL
FDA Approves Unknown Drug — CHARTWELL RX
# FDA Approves Chartwell Rx Generic Drug Application Chartwell Rx has received FDA approval for its abbreviated new drug application (ANDA 207971), e...
Genentech,
FDA Approves PHESGO — Genentech, Inc.
# FDA Approves Genentech's PHESGO as First Subcutaneous Combination HER2 Therapy Genentech's FDA approval of PHESGO (pertuzumab, trastuzumab, and hya...
UCB,
FDA Approves FINTEPLA — UCB, Inc.
# FDA Approves UCB's Fintepla (Fenfluramine) for Rare Seizure Disorder UCB, Inc. received FDA approval for Fintepla (fenfluramine) oral formulation o...
Pfizer
FDA Approves NYVEPRIA — Pfizer Laboratories Div Pfizer Inc
# FDA Approves Pfizer's NYVEPRIA, Expanding Pegfilgrastim Biosimilar Competition The FDA has approved Pfizer's NYVEPRIA (pegfilgrastim-apgf), a biosi...
AMIVAS
FDA Approves Unknown Drug — AMIVAS
# FDA Approves AMIVAS New Drug Application The FDA has approved NDA213036 for AMIVAS, marking a significant expansion of the company's product portfo...
Eli
FDA Approves RETEVMO — Eli Lilly and Company
Eli Lilly and Company received FDA approval for RETEVMO (selmetinib) to treat patients with advanced RET-fusion-positive meningiomas, a significant mi...
RHODES
FDA Approves Unknown Drug — RHODES PHARMS
Rhodes Pharmaceuticals' FDA approval of ANDA205853 facilitates the entry of a generic alternative, a maneuver expected to broaden the company's revenu...