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Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin), Swiss pharma giant Roche announced today. 18 June 2026
Pharmaceutical
GSK and Spero Therapeutics today announced that the US Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil), an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs). 17 June 2026
Biotechnology
Moderna faces a key US Food and Drug Administration (FDA) advisory committee meeting this week for MFLUSIVA (mRNA-1010), its investigational mRNA-based seasonal influenza vaccine. 17 June 2026
Biotechnology
Outlook Therapeutics shares climbed more than 25% to $1.46 on Tuesday, after the company said the US Food and Drug Administration (FDA) has accepted its resubmitted biologics license application (BLA) for ONS-5010/Lytenava as a treatment for age-related macular degeneration (AMD), a condition in which retina damage results in vision loss. 17 June 2026
Biotechnology
M&A featured heavily last week, with Incyte announcing plans to buy Vega Therapeutics, a subsidiary of Star Therapeutics, for up to $2 billion. Then came UK pharma major GSK’s revelation of an agreement to acquire US firm Nuvalent for up to $10.6 billion. Also of note, US biotech Cartesian Therapeutics entered into a licensing deal with China’s WestGene Biopharma on CAR-T therapies for autoimmune diseases. Sweden’s Camurus was served another complete response letter (CRL) by the US Food and Drug Administration (FDA) on its filing for Oclaiz (CAM2029). 14 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to French pharma major Sanofi’s Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D). 13 June 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and prednisone as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. 13 June 2026
Pharmaceutical
Shares in Sweden based drug developer Camurus fell as much as 7% on Thursday, after the US Food and Drug Administration (FDA) rejected the company’s application for Oclaiz (octreotide; CAM2029) extended-release injection a treatment for acromegaly. 12 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs). 11 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review Japan’s largest drugmaker Takeda’s supplemental Biologics License Application (sBLA) for intravenous (IV) Entyvio vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients aged 2 years and older. 10 June 2026
Biotechnology
US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. 8 June 2026
Biotechnology
US biotech Biogen has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for salanersen, its investigational antisense oligonucleotide for spinal muscular atrophy (SMA). 5 June 2026
Pharmaceutical
Shares of US biopharma company Cingulate closed up 11.9% at $4.03 on Tuesday, after it announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for the treatment of attention deficit/hyperactivity disorder (ADHD). 4 June 2026
Biotechnology
The US Food and Drug Administration has issued draft guidance designed to help cell and gene therapy developers make greater use of existing scientific and regulatory knowledge, a move aimed at trimming redundant testing without lowering safety standards. 3 June 2026
Pharmaceutical
The US Food and Drug Administration (FDA) published a final guidance for industry, “Pulmonary Tuberculosis: Developing Drugs for Treatment.” 2 June 2026
Biotechnology
The hereditary angioedema (HAE) pharmaceutical landscape is evolving at an unprecedented speed. Following a surge of approvals in recent years, the market is now facing a late-stage development bottleneck, as 46% of pipeline drugs are currently in Phase III. 1 June 2026
Biotechnology
The US Food and Drug Administration (FDA) and clinical-stage biotech Replimune have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. 1 June 2026
Pharmaceutical
Indian drugmaker Wockhardt (BOM: 532300) has secured a major regulatory breakthrough with the Central Drugs Standard Control Organization (CDSCO) granting approval for the import and marketing of its indigenously discovered antibiotic Zaynich in India. 1 June 2026
Pharmaceutical
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA). 29 May 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
Pharmaceutical
Last week saw AstraZeneca sign an accord with China’s Dizal Pharmaceutical for rights to the latter’s lung cancer drug Zegfrovy. Biogen released new Phase II data its Alzheimer’s candidate diranersen that raised questions. Celcuity won US Food and Drug Administration (FDA) for its investigational breast cancer drug Revtorpyk and Merck & Co announced FDA approval for its oral PCK9 cholesterol drug Lipfendra. Eli Lilly revealed plans to acquire mental health biotech AtaiBeckley for an upfront $2.8 billion. 19 July 2026
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
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