FDA Regulatory News
Refine Search
Biotechnology
US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025
Biotechnology
The US Food and Drug Administration has granted accelerated approval to sunvozertinib (trade name Zegfrovy) from Dizal (Jiangsu) Pharmaceutical for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men. 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025
Biotechnology
US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial. 2 July 2025
Pharmaceutical
Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 2 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, but still sending the California-based company's share shares nearly 5% higher to $5.00. in pre-market activity. 1 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations of amphetamine and methylphenidate—to warn of the risk of weight loss and other adverse reactions in patients younger than six years. 1 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025
article
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi on Frida,y announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor. 28 June 2025
Biotechnology
US pharma major Merck & Co has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season. 27 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. 26 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (previously known as EG-70), Canadian company enGene’s lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). 26 June 2025
Pharmaceutical
Republican Senator Bill Cassidy has called for Wednesday’s meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) to be delayed. 25 June 2025
Pharmaceutical
Nuvalent, a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). 24 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. 24 June 2025
Biotechnology
The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 countries, including emerging and established biotech firms, has taken aim at the powers that be in US healthcare. 23 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Pharmaceutical
Privately-held UK firm Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). 20 June 2025
Biotechnology
US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025
Biotechnology
The US Food and Drug Administration has granted accelerated approval to sunvozertinib (trade name Zegfrovy) from Dizal (Jiangsu) Pharmaceutical for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men. 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025
Biotechnology
US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial. 2 July 2025
Pharmaceutical
Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 2 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, but still sending the California-based company's share shares nearly 5% higher to $5.00. in pre-market activity. 1 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations of amphetamine and methylphenidate—to warn of the risk of weight loss and other adverse reactions in patients younger than six years. 1 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025
article
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi on Frida,y announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor. 28 June 2025
Biotechnology
US pharma major Merck & Co has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season. 27 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. 26 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (previously known as EG-70), Canadian company enGene’s lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). 26 June 2025
Pharmaceutical
Republican Senator Bill Cassidy has called for Wednesday’s meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) to be delayed. 25 June 2025
Pharmaceutical
Nuvalent, a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). 24 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. 24 June 2025
Biotechnology
The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 countries, including emerging and established biotech firms, has taken aim at the powers that be in US healthcare. 23 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Pharmaceutical
Privately-held UK firm Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). 20 June 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze