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FDA greenlight for Takeda's narcolepsy drug Orzeyful

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

FDA accepts application to expand Merck's RSV antibody ENFLONSIA into new season

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

FDA nod for Moderna’s flu vaccine mFlusiva

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

FDA approves expanded indication for Pluvicto

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

The week in pharma: action, reaction and insight – week to July 31, 2026

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

Polpharma Biologics’ Entyvio biosimilar accepted for FDA, EMA review

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

FDA advisory panel backs Replimune’s nivolumab

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

Karyopharm crashes as Phase III XPORT-EC-042 trial misses goal

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

FDA acknowledges Saol’s resubmission for SL1009

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

FDA panel raises doubts over Capricor’s deramiocel data ahead of DMD review

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

Final FDA guidances to expand participation in cancer clinical trials

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

FDA nod for Outlook Therapeutics’ Lytenava at last

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

FDA approval for first-in-class in ADHD drug Simtriyo

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

FDA panel narrowly backs two peptides for compounding list

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

3rd-qrt 2026 Biosimilar Market Report from Samsung Bioepis

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

GSK’s Jideytro approved in USA for previously treated ROS1-positive NSCLC

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

BridgeBio clears key FDA milestone for rare calcium disorder therapy encaleret

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

US House markup of expedited Access to Biosimilars Act welcomed

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

FDA accepts Dyne Duchenne BLA, grants Priority Review

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

FDA accepts Shionogi’s sNDA for Fetroja

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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The week in pharma: action, reaction and insight – week to December 19

Regulatory news of note last week included the US Food and Drug administration (FDA) approving two new treatments for gonorrhea – Innoviva’s Nuzolvence and GSK’s Blujepa. Research news saw positive results for Kyverna mid-stage candidate mivocabtagene-autoleucel (Miv-cel)l and new data from Eli Lilly on its obesity candidate orforglipron. Neurocrine Bioscience held an R&D Day focused on its neuroscience and endocrinology pipeline, notably direclidine and osavampator. 21 December 2025

FDA approves Jascayd for PPF

German family-owned pharma major Boehringer Ingelheim on Friday revealed that its Jascayd (nerandomilast) tablets has now been approved by the US Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. 20 December 2025

FDA approves Cytokinetics’ Myqorzo

The US Food and Drug Administration (FDA) has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. 20 December 2025

Novo Nordisk files for FDA approval of CagriSema

Danish pharma major Novo Nordisk has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for once-weekly CagriSema (cagrilintide and semaglutide) injection, to be used with a reduced-calorie diet and increased physical activity. 19 December 2025

Rybrevant Fasbro approved across all indications of Rybrevant in USA

US healthcare giant Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Rybrevant Fasbro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). 18 December 2025

GSK’s Exdensur approved by FDA for severe asthma

UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. 18 December 2025

Enhertu approved in USA for 1st-line HER2+ metastatic BC

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the USA for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. 16 December 2025

FDA eliminates major barrier to using real-world evidence in reviews

The US Food and Drug Administration (FDA) yesterday removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. 16 December 2025

FDA accepts Sentynl’s CUTX-101 NDA resubmission

The US Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. 15 December 2025

Tenaya fundraising follows resolution of clinical hold

California-based Tenaya Therapeutics, a biotech seeking to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, has announced the pricing of a $60 million public offering. 15 December 2025

FDA approves two oral therapies to treat gonorrhea

The US Food and Drug Administration (FDA) on Friday announced it has approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea. 13 December 2025

BioCryst’s Orladeyo wins expanded FDA approval

The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. 12 December 2025

Priority review for Opdivo and chemo in cHL

US pharma major Bristol Myers Squibb has announced progress for its multi-indication cancer drug Opdivo (nivolumab) in another oncology setting. 11 December 2025

US FDA clears first product under new fast-track voucher scheme

The US Food and Drug Administration has approved a US-manufactured version of Augmentin XR (amoxicillin-clavulanate potassium) through its new Commissioner’s National Priority Voucher pilot, completing the review in two months. The decision marks the first use of the accelerated pathway, which aims to support domestic production of essential drugs. 10 December 2025

‘Revolutionary’ approval for Gamida Cell’s Omisirge

Florida-based cell therapy company Gamida Cell has won US approval for Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). 9 December 2025

FDA column calls for evidence-based trial design for CAR-T therapies in oncology

Vinay Prasad, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), has taken the position that randomized controlled trials (RCTs) should be the standard moving forward for CAR-T cell therapies in cancer. 9 December 2025

FDA accelerated approvals under pressure

The accelerated approval pathway has long represented one of the US Food and Drug Administration’s (FDA) most important tools for speeding access to promising therapies. 7 December 2025

Praxis sets up CNS drug approval in 2026

Praxis Precision Medicines surged 35% with shares reaching a value of $260, their highest value since the beginning of 2022. Current market cap is ~$6.5 billion, after EMBOLD study success and strong pipeline progress, reaching its highest valuation since early 2022. 6 December 2025

FDA nod for Breyanzi as first CAR T therapy for r/r marginal zone lymphoma

The US Food and Drug Administration has approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion. 5 December 2025

Tracy Beth Høeg to replace Richard Pazdur in FDA role

The US Food and Drug Administration (FDA) has announced that Tracy Beth Høeg has been appointed acting director of the Center for Drug Evaluation and Research (CDER). 4 December 2025

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