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Pfizer
FDA Approves HYMPAVZI — Pfizer Laboratories Div Pfizer Inc

# FDA Approves Pfizer's HYMPAVZI for Hemophilia A Treatment Pfizer has received FDA approval for HYMPAVZI (marstacimab-hncq), a subcutaneous therapy ...

Genentech,
FDA Approves ITOVEBI — Genentech, Inc.

# FDA Approves Genentech's ITOVEBI (inavolisib) for PIK3CA-Mutant Breast Cancer Genentech announced FDA approval of ITOVEBI (inavolisib), an oral PI3...

Amneal
FDA Approves PYRIDOSTIGMINE BROMIDE — Amneal Pharmaceuticals LLC

# FDA Approves Amneal Pharmaceuticals' Pyridostigmine Bromide Oral Formulation Amneal Pharmaceuticals LLC received FDA approval for its oral pyridost...

Camber
FDA Approves POMALIDOMIDE — Camber Pharmaceuticals, Inc.

# FDA Approves Generic Pomalidomide; Camber Pharmaceuticals Entry Expected to Intensify Competition Camber Pharmaceuticals, Inc. received FDA approva...

Aurobindo
FDA Approves MYCOPHENOLATE MOFETIL — Aurobindo Pharma Limited

Aurobindo Pharma Limited received FDA approval for oral Mycophenolate Mofetil tablets, a key asset in the chronic immunosuppressant market. The launch...

Meitheal
FDA Approves FLUOROURACIL — Meitheal Pharmaceuticals Inc.

# FDA Approves Meitheal Pharmaceuticals' Generic Fluorouracil Intravenous Formulation The U.S. FDA has approved Meitheal Pharmaceuticals Inc.'s abbre...

Genentech,
FDA Approves OCREVUS ZUNOVO — Genentech, Inc.

Genentech, Inc. received FDA clearance for OCREVUS ZUNOVO, a once-monthly subcutaneous formulation of Ocrelizumab combined with recombinant Hyaluronid...

Eli
FDA Approves EBGLYSS — Eli Lilly and Company

Eli Lilly announced the FDA approval of lebelizumab (EBGLYSS) for atopic dermatitis on September 13; the clearance is expected to impact revenue as th...

Somerset
FDA Approves PROCHLORPERAZINE EDISYLATE — Somerset Therapeutics, LLC

Somerset Therapeutics, LLC announced the September 13, 2024 approval of its and for prochlorperazine edisylate, signalling a robust pipeline that posi...

Genentech,
FDA Approves TECENTRIQ HYBREZA — Genentech, Inc.

# FDA Approves Genentech's TECENTRIQ HYBREZA, Expanding Subcutaneous Administration Options for Cancer Immunotherapy Genentech announced FDA approval...

Amgen,
FDA Approves PAVBLU — Amgen, Inc

# FDA Approves Amgen's PAVBLU, First Biosimilar Aflibercept for Retinal Disease Treatment Amgen announced FDA approval of PAVBLU (aflibercept-ayyh), ...

ARS
FDA Approves NEFFY — ARS Pharmaceuticals Operations, Inc.

# FDA Approves ARS Pharmaceuticals' NEFFY, First Nasal Epinephrine Auto-Injector Alternative ARS Pharmaceuticals Operations, Inc. received FDA approv...

Amneal
FDA Approves CREXONT — Amneal Pharmaceuticals LLC

# FDA Approves Amneal Pharmaceuticals' CREXONT for Parkinson's Disease Treatment Amneal Pharmaceuticals LLC received FDA approval for CREXONT (carbid...

Sun
FDA Approves LEQSELVI — Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries secured FDA approval for the oral deuruxolitinib phosphate formulation branded as LEQSELVI on July 25, 2024, reinforcing...

Teva
FDA Approves EPYSQLI — Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA has secured FDA approval for EPYSQLI (eculizumab-aagh) for intravenous administration, a move expected to intensify competiti...

Teva
FDA Approves PHENTERMINE AND TOPIRAMATE — Teva Pharmaceuticals, Inc.

Teva Pharmaceuticals’ June 25 approval of its generic phentermine and topiramate extended-release tablets introduces a likely price-competitive altern...

UPSHER
FDA Approves Unknown Drug — UPSHER SMITH LABS

# FDA Approves ANDA for Upsher Smith Labs Upsher Smith Laboratories received FDA approval for ANDA216772 on June 12, 2024, expanding its generic drug...

Apotex
FDA Approves POMALIDOMIDE — Apotex Corp.

# FDA Approves Generic Pomalidomide from Apotex Corp. Apotex Corp. has received FDA approval for its generic version of pomalidomide, an oral immunom...

Ipsen
FDA Approves IQIRVO — Ipsen Biopharmaceuticals, Inc.

Ipsen Biopharmaceuticals announced on Thursday the U.S. FDA approval of IQIRVO (elafibranor), marking the entry of the first non-bile acid derivative ...

Geron
FDA Approves RYTELO — Geron Corporation

# FDA Approves Geron Corporation's RYTELO (imetelstat sodium) for Telomerase-Targeted Therapy Geron Corporation received FDA approval for RYTELO (ime...