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Blenrep re-approved by FDA for relapsed/refractory multiple myeloma

The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Blenrep belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma. 24 October 2025

FDA slaps CRL on Mitsubishi Tanabe’s investigational ND0612

Japan’s Mitsubishi Tanabe Pharma (MTPC) yesterday announced that the US Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of its investigational ND0612. 24 October 2025

4th-qtr 2025 US biosimilar market report from Samsung Bioepis

South Korea’s Samsung Bioepis today released its Fourth Quarter 2025 Biosimilar Market Report, marking the eleventh edition of the Quarterly Biosimilar Market Report in the United States (US). 23 October 2025

Astellas sBLA accepted for FDA priority review in bladder cancer

Japanese pharma major Astellas Pharma announced that the US Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for Padcev) (enfortumab vedotin-ejfv) in combination with Merck & Co’s Keytruda (pembrolizumab). 23 October 2025

Replimune bounces back on FDA acceptance of BLA

Oncolytic immunotherapies specialist Replimune Group has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. 21 October 2025

FDA green lights Genentech’s Gazyva for lupus nephritis

Swiss pharma giant Roche’s US subsidiary Genentech yesterday revealed that the US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN). 21 October 2025

FDA accepts Sanofi’s Tzield for expedited review

The US Food and Drug Administration (FDA) has accepted for expedited review French pharma major Sanofi’s supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes (T1D) in adults and pediatric patients eight years of age and older recently diagnosed with stage 3 T1D. 20 October 2025

Novo Nordisk’s oral GLP-1 approved to cut MACE risk in type 2 diabetes patients

The US Food and Drug Administration (FDA) has approved Rybelsus (oral semaglutide) for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they have had a prior CV event or not. 20 October 2025

New FDA approval for Tezspire

The US Food and Drug Administration (FDA) has approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. 20 October 2025

The week in pharma: action, reaction and insight – week to October 17

M&A activity last week saw BioCryst Pharmaceuticals announce it will acquire fellow USA-based Astria Therapeutics along with its navenibart for the treatment of hereditary angioedema, boosting its own HAE portfolio for around $700 million. US healthcare giant Johnson & Johnson was the first out of the big pharma block reporting third-quarter financial results, which were better than expected. On the regulatory front, Disc Medicine received a priority review voucher from the US Food and Drug Administration (FDA) for its bitopertin, a potential treatment for erythropoietic protophyria. Also of note, Sino American biotech I-Mab announced a wide-ranging strategic overhaul, including a rebranding. 19 October 2025

Priority voucher for Disc Medicine's bitopertin

US hematology specialist Disc Medicine shares surged 19.7% in after-hours trading Thursday after the company announced it received a Commissioner’s National Priority Voucher (CNPV) from the U.S. Food and Drug Administration for its drug bitopertin X-linked protoporphyria (XLP). 17 October 2025

BeOne’s sonrotoclax granted FDA Breakthrough Therapy designation

Sino-American oncology specialist BeOne Medicines has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for sonrotoclax, a potentially best-in-class investigational BCL2 inhibitor, for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL). 16 October 2025

Scholar Rock shares suffer on manufacturing site woes

Shares in US biopharma Scholar Rock closed 13% lower Monday after bad news on its spinal muscular atrophy (SMA) treatment apitegromab. 14 October 2025

Bicara Thera earns FDA Breakthrough status for ficerafusp alfa

Boston, USA-based Bicara Therapeutics, a biotech focused on developing bifunctional therapies for solid tumors, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for. its ficerafusp alfa in combination with Merck & Co’s Keytruda (pembrolizumab). 14 October 2025

Regeneron plans FDA filing based on latest DB-OTO data

US biotech Regeneron Pharmaceuticals has announced positive updated data for its investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene and revealed plans to progress the product into regulatory filing. 13 October 2025

FDA approves labeling changes for Janssen’s Carvykti

The US Food and Drug Administration (FDA) on Friday revealed it has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy from Johnson & Johnson subsidiary Janssen. 13 October 2025

The week in pharma: action, reaction and insight – week to October 10

Significant research news last week included French biotech Abivax releasing positive new Phase III data on obefazimod for ulcerative colitis. On the regulatory front, the US Food and Drug Administration (FDA) approved German pharma major Boehringer Ingelheim’s Jascayd, making it the first to gain approval for a new idiopathic pulmonary fibrosis treatment in over decade. M&A news saw Denmark’s Novo Nordisk announce plans to expand its metabolic dysfunction-associated steatohepatitis (MASH) portfolio with the buy of US biotech Akero Therapeutics along with its investigational drug efruxifermin for $4.7 billion, as well as US pharma major Bristol Myers Squibb enter a deal worth around $1.5 billion to acquire Orbital Therapeutics, gaining access to its lead asset OTX-201 for autoimmune diseases. 12 October 2025

Celltrion wins FDA approval for Eydenzelt

South Korea-based Celltrion on Friday announced that the US Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Bayer’s Eylea (aflibercept). 11 October 2025

Xspray’s Dasynoc NDA thwarted by manufacturing issues

Swedish oncology specialist Xspray Pharma has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). 10 October 2025

Cidara wins FDA “Breakthrough” status for CD388

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

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GSK’s Amanda Peppercorn on bringing the first oral carbapenem to cUTI patients

The US Food and Drug Administration’s (FDA) approval of Utebzi (tebipenem pivoxil) gives physicians the first oral carbapenem option for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no alternative oral treatment options. 17 July 2026

Novartis’ Fabhalta wins FDA traditional approval

Swiss pharma giant Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 17 July 2026

Merck & Co’s cholesterol cutting drug Lipfendra wins FDA approval

US pharma major Merck today revealed it has gained US Food and Drug Administration (FDA) approval for Lipfendra (enlicitide) tablets 20mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. 16 July 2026

FDA grants priority review to Genentech’s Gazyva sBLA in pMN

For the first time, a treatment specifically designed to address primary membranous nephropathy (pMN) is moving closer to US Food and Drug Administration (FDA) approval. 15 July 2026

Celcuity wins first FDA approval with Revtorpyk in advanced breast cancer

USA-based biotech Celcuity has won its first US Food and Drug Administration (FDA) approval, with the regulator clearing Revtorpyk (gedatolisib) for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one line of endocrine therapy in the metastatic setting. 15 July 2026

FDA grants approval for at-home Leqembi start

Eisai and Biogen have secured US approval for patients to begin treatment with an at-home version of their Alzheimer’s medicine Leqembi Iqlik (lecanemab-irmb), removing the need to start therapy through intravenous infusions. 14 July 2026

FDA proposal to modernize drug manufacturing registration

The US Food and Drug Administration (FDA) on Friday issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. 13 July 2026

The week in pharma: action, reaction and insight – week to July 10, 2026

Last week’s regulatory news saw the US Food and Drug Administration (FDA) accept Swiss biotech Pharmvaris’ new drug application (NDA) for deucrictibant for the treatment hereditary angioedema (HAE) attacks. The FDA also approved Sanofi’s Sarclisa Escensa. On the M&A front, US drugmaker Vertex announced a $10 billion takeover bid for Crinetics and its rare disease drug Palsonify. Also of note, the UK’s AstraZeneca released disappointing Phase III trial results for its Wainua in cardiopathy. 12 July 2026

Padcev-Keytruda wins broader FDA approval in bladder cancer

The US Food and Drug Administration (FDA) has approved pharma giant Pfizer and Japanese drugmaker Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) plus Merck & Co’s Keytruda (pembrolizumab) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. 10 July 2026

FDA accepts sNDA for Arcutis’ Zoryve

The US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months, said Arcutis Biotherapeutics. 9 July 2026

Merck KGaA wins FDA Breakthrough status for enpatoran

vGerman pharma and life science company Merck KGaA today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. 8 July 2026

FDA-awarded RMAT designations continue to surge in 2025

Since the US Food and Drug Administration (FDA) first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023. 8 July 2026

FDA Orphan Drug and Rare Pediatric Disease designations for tegacorat

German family-owned drugmaker Grünenthal today announced that its investigational compound tegacorat (GRM-01) received Orphan Drug and Rare Pediatric Disease designations from the US Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). 8 July 2026

Vera Therapeutics wins FDA accelerated approval for Trutakna

The US Food and Drug Administration (FDA) has granted US biotech Vera Therapeutics’ Trutakna (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression. 8 July 2026

Saol Therapeutics resubmits NDA for SL1009

Privately held, clinical-stage US pharmaceutical company Saol Therapeutics today announced the resubmission of its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease. 7 July 2026

FDA accepts Pharvaris NDA for oral hereditary angioedema treatment

Swiss biotech Pharvaris has moved a step closer to the US market after the Food and Drug Administration (FDA) accepted its New Drug Application for deucrictibant immediate-release capsules as an on-demand treatment for hereditary angioedema (HAE) attacks. 6 July 2026

The week in pharma: action, reaction and insight – week to July 3, 2026

In last week’s news, US biotech Replimune’s resubmitted biologicals license application (BLA) for RP1 (vusolimogene oderparepvec) was accepted by the Food and Drug Administration. On the M&A front, Zymeworks announced plans to acquire Theravance Biopharma and its key product Yupelri for COPD. French drugmaker Ipsen revealed plans to buy Kartos Therapeutics for an upfront $450 million, gaining rights to the latter’s navtemadlin. Ipsen then went to bid up to $1.75 billion for Memo Therapeutics and potravitug. Also, BioCrsyt Pharma revealed plans to wind down its internal discovery programs. 5 July 2026

FDA expands Casgevy approval to children as young as two

The US Food and Drug Administration has expanded approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) to patients aged two years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT). 2 July 2026

Orca Bio’s Tregzi wins FDA approval

Privately-held US cell therapy company Orca Bio announced the US Food and Drug Administration (FDA) has approved Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T. 1 July 2026

FDA approves expanded use for Arcutis’ Zoryve cream

US Immuno-dermatology specialist Arcutis announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. 30 June 2026

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