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Jun 23 FDA Approves LITFULO — Pfizer Laboratories Div Pfizer IncJun 15 FDA Approves COLUMVI — Genentech, Inc.May 25 FDA Approves PAXLOVID — Pfizer Laboratories Div Pfizer IncMay 23 FDA Approves HALOPERIDOL DECANOATE — NorthStar RxLLCMay 23 FDA Approves FEXOFENADINE HYDROCHLORIDE — Aurohealth LLC
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FDA · 22,616 results Live
FDA Pfizer Jun 23 — 0.00

FDA Approves LITFULO — Pfizer Laboratories Div Pfizer Inc

Pfizer has announced the FDA approval of the oral drug Ritlecitinib Tosylate (LITFULO) for the treatment of alopecia areata, marking the pharma giant's latest expansion into the co…

FDA Genentech, Jun 15 — 0.00

FDA Approves COLUMVI — Genentech, Inc.

Genentech, Inc. received FDA approval in June 2023 for its intravenous antibody drug Glufitamab under the brand name COLUMVI, a significant milestone for the company’s portfolio of…

FDA Pfizer May 25 — 0.00

FDA Approves PAXLOVID — Pfizer Laboratories Div Pfizer Inc

# FDA Approves Pfizer's Paxlovid as Antiviral Treatment Pfizer announced FDA approval of Paxlovid (nirmatrelvir and ritonavir) on May 25, 2023, solidifying the company's position …

FDA NorthStar May 23 — 0.00

FDA Approves HALOPERIDOL DECANOATE — NorthStar RxLLC

# FDA Approves NorthStar RxLLC's Haloperidol Decanoate for Intramuscular Administration The FDA has approved NorthStar RxLLC's haloperidol decanoate intramuscular injection (ANDA2…

FDA Aurohealth May 23 — 0.00

FDA Approves FEXOFENADINE HYDROCHLORIDE — Aurohealth LLC

**Aurohealth LLC received FDA approval on May 23 for its ANDA 213466 for FEXOFENADINE HYDROCHLORIDE Oral, introducing an additional generic alternative to the widely subscribed ant…

FDA Camber May 11 — 0.00

FDA Approves LENALIDOMIDE — Camber Pharmaceuticals, Inc.

Camber Pharmaceuticals, Inc. announced the FDA’s approval of its ANDA for oral Lenalidomide, granting the company a license to market a generic version of the drug and intensifying…

FDA WG May 8 — 0.00

FDA Approves CEFAZOLIN — WG Critical Care, LLC

# FDA Approves WG Critical Care's Intravenous Cefazolin Formulation WG Critical Care, LLC received FDA approval for its intravenous cefazolin sodium injection (NDA211413), a broad…

FDA ASTRAZENECA Apr 28 — 0.00

FDA Approves Unknown Drug — ASTRAZENECA

On April 28, 2023, AstraZeneca received FDA approval for its experimental anti-inflammatory drug, a landmark clearance likely to enhance the company's position in the rapidly growi…

FDA NATCO Apr 27 — 0.00

FDA Approves Unknown Drug — NATCO

NATCO announced today that the FDA has approved Abbreviated New Drug Application (ANDA) 213267, dated April 27, 2023. This regulatory clearance is expected to reshape market dynami…

FDA GlaxoSmithKline Apr 26 — 0.00

FDA Approves ZEJULA — GlaxoSmithKline LLC

# FDA Approves GlaxoSmithKline's ZEJULA (Niraparib Tosylate) for Oral Administration GlaxoSmithKline LLC has received FDA approval for ZEJULA (niraparib tosylate), an oral PARP in…

FDA Vertex Apr 26 — 0.00

FDA Approves TRIKAFTA — Vertex Pharmaceuticals Incorporated

Vertex Pharmaceuticals Incorporated secured FDA approval for TRIKAFTA, reinforcing the company’s market dominance in the cystic fibrosis sector and driving revenue forecasts as the…

FDA ScieGen Apr 6 — 0.00

FDA Approves DILTIAZEM HYDROCHLORIDE — ScieGen Pharmaceuticals, Inc.

ScieGen Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application (ANDA) 216327, granting it market rights to the generic version of Diltiazem Hydrochloride…

FDA Aurobindo Mar 29 — 0.00

FDA Approves PREGABALIN — Aurobindo Pharma Limited

Oncedem Pharmaceuticals (formerly Aurobindo Pharma) announced the approval of its generic pregabalin tablets, a move expected to position the company as a major player in the US ma…

FDA Incyte Mar 22 — 0.00

FDA Approves ZYNYZ — Incyte Corporation

# FDA Approves Incyte's ZYNYZ (retifanlimab-dlwr), Expanding the Company's Oncology Portfolio Incyte Corporation announced FDA approval of ZYNYZ (retifanlimab-dlwr), an intravenou…

FDA Novartis Mar 16 — 0.00

FDA Approves TAFINLAR — Novartis Pharmaceuticals Corporation

Novartis faces heightened competitive pressure as the FDA approves generic Dabrafenib mesylate for oral use, threatening to undermine the revenue of the company's branded TAFINLAR …

FDA Novartis Mar 16 — 0.00

FDA Approves MEKINIST — Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation has received FDA approval for MEKIST (trametinib) dimethyl sulfoxide, marking an update to an existing product line. This approval retains the …

FDA Zydus Mar 14 — 0.00

FDA Approves TOFACITINIB — Zydus Pharmaceuticals USA Inc.

Zydus Pharmaceuticals USA Inc. secured FDA approval for its generic version of Tofacitinib Citrate, positioning the firm to capture significant market share and drive additional re…

FDA Acadia Mar 10 — 0.00

FDA Approves DAYBUE — Acadia Pharmaceuticals Inc.

# FDA Approves Acadia Pharmaceuticals' DAYBUE (trofinetide) for Rare Neurological Disorder Acadia Pharmaceuticals Inc. received FDA approval for DAYBUE (trofinetide), an oral trea…

FDA Aurobindo Mar 10 — 0.00

FDA Approves LURASIDONE HYDROCHLORIDE — Aurobindo Pharma Limited

# FDA Approves Generic Lurasidone Hydrochloride; Aurobindo Pharma Enters Antipsychotic Market Aurobindo Pharma Limited has received FDA approval for its generic formulation of lur…

FDA International Mar 7 — 0.00

FDA Approves REXTOVY — International Medication Systems, Ltd.

International Medication Systems, Ltd. received FDA approval for its nasally administered naloxone hydrochloride (Rextovy, NDA208969) on March 7, 2023, potentially expanding the co…