FDA Regulatory News
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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The US Food and Drug Administration has issued draft guidance designed to help cell and gene therapy developers make greater use of existing scientific and regulatory knowledge, a move aimed at trimming redundant testing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
Pharmaceutical
Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). 29 May 2026
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the USA for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). 29 May 2026
Generics
The US Food and Drug Administration (FDA) yesterday published two final guidances for industry related to establishing bioequivalence. 29 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for Sanofi’s venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder. 28 May 2026
Pharmaceutical
US biotech Ironwood Pharmaceuticals, which is developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the US Food and Drug Administration (FDA) has approved the use of Linzess (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC).
L 28 May 2026
Pharmaceutical
BridgeBio Pharma announced that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) with priority review for oral BBP-418 to treat individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 28 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant. 27 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval for Gilead Sciences’ Hepcludex (bulevirtide-gmod) 8.5mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the USA, and sending the firm’s shares up 3% to $134.36 by close on Friday. 23 May 2026
Biotechnology
AstraZeneca and Daiichi Sankyo have secured US approval for Datroway (datopotamab deruxtecan-dlnk) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy. 22 May 2026
Pharmaceutical
Bayer has announced that the US Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia (finerenone), which is being investigated for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). 21 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare have accepted New Drug Applications (NDA) for the investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). 19 May 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
Pharmaceutical
Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). 29 May 2026
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the USA for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). 29 May 2026
Generics
The US Food and Drug Administration (FDA) yesterday published two final guidances for industry related to establishing bioequivalence. 29 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for Sanofi’s venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder. 28 May 2026
Pharmaceutical
US biotech Ironwood Pharmaceuticals, which is developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the US Food and Drug Administration (FDA) has approved the use of Linzess (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC).
L 28 May 2026
Pharmaceutical
BridgeBio Pharma announced that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) with priority review for oral BBP-418 to treat individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 28 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant. 27 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval for Gilead Sciences’ Hepcludex (bulevirtide-gmod) 8.5mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the USA, and sending the firm’s shares up 3% to $134.36 by close on Friday. 23 May 2026
Biotechnology
AstraZeneca and Daiichi Sankyo have secured US approval for Datroway (datopotamab deruxtecan-dlnk) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy. 22 May 2026
Pharmaceutical
Bayer has announced that the US Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia (finerenone), which is being investigated for the treatment of adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). 21 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare have accepted New Drug Applications (NDA) for the investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). 19 May 2026
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Company Spotlight
A clinical-stage biotechnology company developing disease-modifying treatments for neurodegenerative diseases, with a primary focus on amyotrophic lateral sclerosis (ALS) and broader neurodegenerative biology. Neurizon aims to advance its lead small-molecule candidate into pivotal clinical testing and position it for regulatory evaluation and eventual patient access.
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