AATP Interactive

Drug Approvals

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy
Basel, April 3, 2025 – Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of...
View Pub Date: Thu, 03 Apr 2025 18:04:15 +0000

Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine
COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of Jynneos® (Smallpox and Mpox Vaccine, Live, Non-replicating)...
View Pub Date: Mon, 31 Mar 2025 01:03:18 +0000

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors
Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric...
View Pub Date: Fri, 28 Mar 2025 06:03:19 +0000

FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer
On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for...
View Pub Date: Fri, 28 Mar 2025 03:03:32 +0000

FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic...
View Pub Date: Fri, 28 Mar 2025 00:03:43 +0000

FDA Approves Bomyntra (denosumab-bnht), a Biosimilar to Xgeva
LAKE ZURICH, Ill., March 27, 2025 -- Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug...
View Pub Date: Thu, 27 Mar 2025 01:03:18 +0000

FDA Approves Conexxence (denosumab-bnht), a Biosimilar to Prolia
LAKE ZURICH, Ill., March 27, 2025 -- Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Conexxence (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug...
View Pub Date: Thu, 27 Mar 2025 00:03:04 +0000

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 26, 2025-- Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved Cabometyx (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of...
View Pub Date: Wed, 26 Mar 2025 19:03:31 +0000

FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi Syndrome
REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug...
View Pub Date: Wed, 26 Mar 2025 02:03:29 +0000

FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections
London, UK -- 25 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg)...
View Pub Date: Tue, 25 Mar 2025 18:03:51 +0000

Theratechnologies Receives FDA Approval for Egrifta WR (tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced that the U.S. Food and Drug...
View Pub Date: Tue, 25 Mar 2025 05:03:22 +0000

FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging
Melbourne Australia | 21 March 2025 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga)...
View Pub Date: Fri, 21 Mar 2025 03:03:15 +0000

Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan), the First and Only Treatment Approved in C3 Glomerulopathy
Basel, March 20, 2025 – Novartis today announced that oral Fabhalta (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first...
View Pub Date: Fri, 21 Mar 2025 01:03:37 +0000

FDA Approves Tremfya (guselkumab) for Adult Patients with Moderately to Severely Active Crohn’s Disease
HORSHAM, Pa. (March 20, 2025) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and...
View Pub Date: Thu, 20 Mar 2025 03:03:30 +0000

Alnylam Announces FDA Approval of Amvuttra (vutrisiran), the First RNAi Therapeutic to Reduce Cardiovascular Death, Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 20, 2025-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application...
View Pub Date: Thu, 20 Mar 2025 00:03:18 +0000

FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥1)
On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced...
View Pub Date: Wed, 19 Mar 2025 21:03:01 +0000

FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.
TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through...
View Pub Date: Tue, 18 Mar 2025 18:03:34 +0000

ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label
BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Iluvien (fluocinolone acetonide...
View Pub Date: Fri, 14 Mar 2025 21:03:06 +0000

FDA Approves Expanded Use of Soliris (eculizumab) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children
New York, March 10, 2025 – The Muscular Dystrophy Association (MDA) welcomes the U.S. Food and Drug Administration (FDA) approval of the expanded indication of Alexion/AstraZeneca’s eculizumab (Soliris) for pediatric patients aged six...
View Pub Date: Mon, 10 Mar 2025 04:03:23 +0000

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair
JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved Omlyclo® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with Xolair®...
View Pub Date: Fri, 07 Mar 2025 22:03:12 +0000

scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease
BURLINGTON, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today...
View Pub Date: Fri, 07 Mar 2025 00:03:47 +0000

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)
CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved Encelto...
View Pub Date: Thu, 06 Mar 2025 22:03:16 +0000

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients
SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to...
View Pub Date: Wed, 05 Mar 2025 02:03:11 +0000

Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy
SAN MATEO, Calif.--(BUSINESS WIRE) Mar 04, 2025 -- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the U.S. Food and Drug Administration (FDA)...
View Pub Date: Tue, 04 Mar 2025 02:03:13 +0000

FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults
South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving...
View Pub Date: Mon, 03 Mar 2025 22:03:08 +0000