FDA Regulatory News
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Biotechnology
San Diego, USA-based biotech Cidara Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents. 9 October 2025
Biotechnology
US biotech Regeneron Pharmaceuticals revealed that the US Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. 9 October 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is stepping up collaboration with the US Food and Drug Administration (FDA) to speed access to new medical technologies and artificial intelligence tools, while aiming to improve patient safety and cut trade barriers. 9 October 2025
Biotechnology
UK pharma major GSK’s clinical data for depemokimab positions the asset for potential Food and Drug Administration (FDA) approval in asthma and chronic rhinosinusitis, according to reporting by the insights investigative news team at GlobalData. 8 October 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare, serious, and progressive disease with no cure and limited treatments. This is the first new therapy approved in more than 10 years for IPF, the agency noted. 8 October 2025
Biotechnology
Privately-held cell therapy company Orca Bio has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T. 7 October 2025
Pharmaceutical
Australian biotech Neurizon Therapeutics said the US regulator has lifted the clinical hold on its lead drug NUZ-001 (monepantel) for amyotrophic lateral sclerosis, clearing the way for Phase II/III evaluation within the HEALEY ALS platform trial. Patient enrolment is expected to begin in the fourth quarter. 7 October 2025
Biosimilars
Hungary’s largest drugmaker Gedeon Richter has received approval for its biosimilar products for the first time following a multi-agency inspection conducted by the US Food and Drug Administration (FDA). 6 October 2025
Generics
The US Food and Drug Administration (FDA) announced a new prioritization pilot program for abbreviated new drug applications (ANDAs) that aims to spur and reward investment in US drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the USA. 4 October 2025
Biotechnology
US late-stage biotech Rocket Pharmaceuticals today announced via a Securities Exchange filing that it has voluntarily withdrawn its Biologics License Application (BLA) to the US Food and Drug Administration for mozafancogene autotemcel, also known as RP-L102, an investigational gene therapy for the treatment of Fanconi anemia. 3 October 2025
Pharmaceutical
Ireland-based Jazz Pharmaceuticals has announced the US Food and Drug Administration (FDA) approval of Zepzelca (lurbinectedin) alongside Roche’s Tecentriq (atezolizumab) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. 3 October 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets, Texas, USA-based clinical-stage biotech Nacuity Pharmaceuticals’ proprietary, investigational therapy for the treatment of patients with retinitis pigmentosa (RP). 3 October 2025
Biotechnology
US biopharma Fortress Biotech saw its shares tumble by more than 30% Wednesday after the Florida firm revealed an update on its New Drug Application (NDA) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. 2 October 2025
Pharmaceutical
The US Food and Drug Administration (FDA) will not be able to deal with new drug applications amid the federal government shutdown. 2 October 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. 1 October 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Tremfya (guselkumab) to treat children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). 29 September 2025
Pharmaceutical
Last week’s significant news included US pharma giant Pfizer’s takeover bid for obesity drug developer Metsera for up to $7.3 billion. French biotech Genfit announced disappointing results for its liver disease candidate VS-01 and its decision to terminate the program. On the research front, US biotech Scholar Rock received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its spinal muscular atrophy candidate apitegromab. The US FDA last week also revealed it has started a a review of UK pharma major GSK’s filing for approval of its leucovorin for the potential treatment of autism. 28 September 2025
Pharmaceutical
Chicago-based drugmaker AbbVie has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease. 26 September 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. 26 September 2025
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday approved Eli Lilly’s Inluriyo (imlunestrant, 200mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). 26 September 2025
Pharmaceutical
The US Food and Drug Administration has approved Japanese pharma major Takeda’s Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. The company’s shares rose 3% to 5,425 yen on the news. 6 August 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted Merck & Co's supplemental Biologics License Application (sBLA) for its respiratory syncytial virus (RSV) antibody Enflonsia (clesrovimab-cfor), seeking to expand its indication to children under two years old at increased risk of severe RSV disease through their second RSV season. 6 August 2026
Biotechnology
Cambridge, USA-based mRNA vaccines company Moderna announced that the US Food and Drug Administration (FDA) has approved mFlusiva (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. 6 August 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC), Swiss pharma giant Novartis revealed late Friday. 3 August 2026
Biotechnology
M&A news last week saw Belgo-Dutch firm argenx announce a deal to acquire Forte Biosciences, and its FB102, for around $2.2 billion, and Johnson & Johnson inked a collaboration with Sail Biosciences including an option to buy the company. UK pharma major GSK announced better than expected 2nd-qtr financials and growth plans. Also, the US Food and Drug Administration (FDA) issued negative briefing documents on US biotech Capricor Therapeutics’ deramiocel for the treatment of Duchenne muscular dystrophy. 2 August 2026
Biosimilars
Privately-held Swiss firm Polpharma Biologics says the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review regulatory filings for PB016, its proposed biosimilar to Takeda’s Entyvio (vedolizumab). 31 July 2026
Biotechnology
The US Food and Drug Administration’s (FDA) advisory committee voted 10 to 3 that the efficacy results from Replimune's IGNYTE study on RP1 combined with nivolumab for advanced melanoma are evaluable and clinically meaningful. 31 July 2026
Pharmaceutical
US cancer focused pharma Karyopharm Therapeutics shares plunged 68.47% to $7.01 in Thursday’s after-hours trading, after the company reported results from its Phase III trial which failed meet its primary goal. 31 July 2026
Pharmaceutical
Privately held, US clinical-stage pharma Saol Therapeutics announced that the US Food and Drug Administration (FDA) has acknowledged the company's resubmission of its New Drug Application (NDA) for SL1009, sodium dichloroacetate (DCA). 29 July 2026
Biotechnology
Biotech company Capricor Therapeutics faces heightened regulatory uncertainty after US Food and Drug Administration (FDA) reviewers questioned whether its resubmitted Biologics License Application for deramiocel provides substantial evidence of effectiveness in cardiomyopathy in male patients with Duchenne muscular dystrophy. 28 July 2026
Pharmaceutical
The US Food and Drug Administration’s (FDA) Oncology Center of Excellence has announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. 28 July 2026
Biotechnology
US biotech Outlook Therapeutics revealed that the US Food and Drug Administration (FDA) has approved Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. 27 July 2026
Pharmaceutical
The US unit of Japan’s Otsuka has been granted US Food and Drug Administration (FDA) approval for Simtriyo (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder (ADHD). 25 July 2026
Pharmaceutical
An advisory panel to the US Food and Drug Administration (FDA) has narrowly recommended that two peptides be added to the list of substances eligible for pharmacy compounding, in a closely watched test of how far the agency will loosen access to a group of popular but largely unproven products. 24 July 2026
Biosimilars
South Korean biosimilars developer Samsung Bioepis today released its Third Quarter 2026 Biosimilar Market Report, marking the 14th edition of the Quarterly Biosimilar Market Report in the USA. 23 July 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received a prior ROS1 kinase inhibitor. 23 July 2026
Pharmaceutical
BridgeBio Pharma has moved closer to bringing a first targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1) to market after the US Food and Drug Administration (FDA) accepted its New Drug Application for encaleret. 22 July 2026
Biosimilars
The US Biosimilars Council and the Association for Accessible Medicines (AAM) have lauded legislative progress as the House Energy and Commerce Committee marked up and voted to approve the Expedited Access to Biosimilars Act and the Biosimilars Red Tape Elimination Act. 22 July 2026
Biotechnology
US biotech Dyne Therapeutics has moved closer to a possible first approval after the US Food and Drug Administration accepted its biologics license application for zeleciment rostudirsen, or z-rostudirsen, in Duchenne muscular dystrophy. 20 July 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Shionogi’s supplemental New Drug Application (sNDA) for Fetroja (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms. 20 July 2026
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