FDA Approves VEKLURY — Gilead Sciences, Inc.
The FDA’s approval of Gilead Sciences, Inc.’s intravenous remdesivir (VEKLURY) marks a significant milestone for the company’s antiviral portfolio, potentially cementing the produc…
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The FDA’s approval of Gilead Sciences, Inc.’s intravenous remdesivir (VEKLURY) marks a significant milestone for the company’s antiviral portfolio, potentially cementing the produc…
# FDA Approves Harmony Biosciences' WAKIX for Narcolepsy Treatment Harmony Biosciences announced FDA approval of WAKIX (pitolisant hydrochloride), an oral histamine H3-receptor an…
# FDA Approves Lifestar Pharma's Generic Acetazolamide The U.S. Food and Drug Administration has approved Lifestar Pharma LLC's abbreviated new drug application for generic acetaz…
SpecGx LLC has secured FDA approval for the generic oral formulation of Diphenoxylate Hydrochloride and Atropine Sulfate, positioning the company to enter the market and increase c…
Pfizer’s FDA approval of XELJANZ reinforces its competitive position in the rheumatology market, expected to drive incremental sales growth as it captures share from existing biolo…
Avet Pharmaceuticals Inc. announced FDA approval of its Abbreviated New Drug Application for oral acyclovir, potentially strengthening its position in the generic antiviral market.…
# FDA Approves Celgene's ONUREG (Azacitidine) as First Oral Maintenance Therapy for AML The FDA approval of Celgene Corporation's ONUREG (azacitidine) marks a significant market o…
TruPharma, LLC announced on Monday the implementation of the 180-day generic exclusivity period for its 50 mg and 100 mg oral tramadol hydrochloride tablets (NDA 214044), a compoun…
Accord Healthcare announced FDA approval for a new drug application on Aug. 24, 2020, which market analysts expect to broaden the company’s product portfolio and drive incremental …
# FDA Approves Generic Gabapentin from Zhejiang Yongtai Pharmaceutical The U.S. Food and Drug Administration has approved Zhejiang Yongtai Pharmaceutical Co., Ltd.'s generic formu…
# FDA Approves Genentech's ENSPRYNG for Neuromyelitis Optica Spectrum Disorder The FDA has approved Genentech's ENSPRYNG (satralizumab), a subcutaneous monoclonal antibody therapy…
# FDA Approves Genentech's EVRYSDI (risdiplam) for Spinal Muscular Atrophy Genentech announced FDA approval of EVRYSDI (risdiplam), an oral treatment for spinal muscular atrophy, …
Astellas Pharma Inc. received FDA approval for its oral androgen receptor antagonist Enzalutamide, assigned the brand name XTANDI, to treat certain metastatic prostate cancer patie…
Concord Biotech Limited won approval for its ANDA212087 on July 31, 2020, for the oral product Mycophenolate Mofetil, indicating the company is positioned to enter the generic mark…
# FDA Approves Ingenus Pharmaceuticals' Oral Leucovorin Calcium Generic Ingenus Pharmaceuticals, LLC has received FDA approval for oral leucovorin calcium (ANDA211132), expanding …
# FDA Approves AstraZeneca's BREZTRI for COPD Treatment AstraZeneca Pharmaceuticals LP received FDA approval for BREZTRI (budesonide, glycopyrrolate, and formoterol fumarate), a o…
# FDA Approves Generic Imatinib Mesylate by BluePoint Laboratories BluePoint Laboratories received FDA approval for its generic formulation of imatinib mesylate, a breakthrough ty…
The FDA has approved a sublingual formulation of buprenorphine and naloxone hydrochloride dihydrate from Accord Healthcare, expanding access to this essential medication for opioid…
Epic Pharma, LLC received FDA approval for its ANDA040910 on July 16, 2020, to manufacture and market generic oxycodone and aspirin in oral tablets. This approval expands the manuf…
ANI Pharmaceuticals, Inc. announced the acceptance of its Abbreviated New Drug Application (ANDA212252) for acyclovir, a formulation intended for oral use. This approval is anticip…