FDA Regulatory News
Refine Search
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday approved Abrysvo (respiratory syncytial virus vaccine). 23 October 2024
Biotechnology
Shares in Sangamo Therapeutics surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy ST-920 (isaralgagene civaparvovec) for Fabry disease. 23 October 2024
Pharmaceutical
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Biotechnology
Biotech firm Gilead Sciences has announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 21 October 2024
Biotechnology
The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine and platinum-containing chemotherapy, from Japanese drug major Astellas Pharma. 19 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has placed a partial clinical hold on the two-stage, open-label, randomized Phase III trial, PRESERVE-003 (NCT05671510). 18 October 2024
Pharmaceutical
Last week’s regulatory news featured Eli Lilly gaining US Food and Drug Administration approval for its CGRP inhibitor Emgality as a treatment for episodic cluster headache, the first company to get such an indication, and Epizyme filed for accelerated approval for its tazemetostat for epitheloid sarcoma. Among research news, Takeda announced that it is abandoning A Phase III trial of Ninlaro in amyloidosis, while Amgen’s early-stage trial of AMG-510 caused quite a stir at the ASCO meeting. In deal-making news, Vertex Pharmaceuticals revealed it plans to acquire Exonics and entered into a deal with CRISPR Therapeutics, both to expand its presence in the Duchenne muscular dystrophy arena. 9 June 2019
Biotechnology
Shares in UK-based antibiotics developer Motif Bio are now worth just a tenth of their value of four months ago after more bad news about iclaprim, the company’s lead product. 7 June 2019
Biotechnology
The US Food and Drug Administration yesterday approved marketing of autoinjector and prefilled safety syringe versions of GlaxoSmithKline's asthma drug Nucala (mepolizumab), enabling self-administration of the monthly dose of the interleukin (IL)-5 inhibitor. 7 June 2019
Pharmaceutical
The US Food and Drug Administration has approved the new drug application (NDA) for Slynd containing drospirenone 4mg, an oral contraceptive tablet for pregnancy prevention. 7 June 2019
Biotechnology
Celgene has provided cause for celebration for Bristol-Myers Squibb, which is set to take over the US biotech company, and its partner Acceleron Pharma. 5 June 2019
Biotechnology
The US Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat pediatric congenital athymia, and granted Priority Review. 5 June 2019
Biotechnology
The US Food and Drug Administration has approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. 5 June 2019
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the New Drug Application for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes. 4 June 2019
Pharmaceutical
The US Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. 4 June 2019
Pharmaceutical
Regulatory decisions last week including good news for Novartis and not so good for Newron Pharmaceuticals. For the Swiss pharma giant, the US Food and Drug Administration granted approval for its spinal muscular atrophy drug Zolgensma (SMA), but it also comes with a hefty price tag of over $2 million. Italy’s Newron had a set back with the FDA delaying studies of its schizophrenia candidate evenamide. On the price front, the UK’s cost-effectiveness body the National Institute for Health and Care Excellence (NICE) gave its backing for Merck & Co’s Prevymis for the treatment on cytomegalovirus. Executive shuffles last week included Gilead Sciences naming a new chief commercial officer, nabbing a Bristol-Myers Squibb exec for the role. 2 June 2019
Biotechnology
Japanese drug major Astellas Pharma today announced that the US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. 31 May 2019
Pharmaceutical
US biopharma company Epizyme has submitted a New Drug Application (NDA) to the US Food and Drug Administration for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. 31 May 2019
Biotechnology
Vertex Pharmaceuticals says it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). 31 May 2019
Biotechnology
The share price of Canadian biopharma Zymeworks (TSX: ZYME) closed 4% up on Wednesday after the company received two separate validations of its approach. 30 May 2019
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. 29 May 2019
Biotechnology
The US Food and Drug Administration has approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. 29 May 2019
Biotechnology
Italian biopharma Newron Pharmaceuticals looked set to close around 13% down on Tuesday after bad news was announced surrounding evenamide, a potential add-on therapy for the treatment of patients with positive symptoms of schizophrenia. 28 May 2019
Biotechnology
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older 28 May 2019
Biotechnology
The US Food and Drug Administration on Friday approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality. 25 May 2019
Biotechnology
Biotherapeutics revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for its TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy. 24 May 2019
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze