Regulation
Refine Search
Biotechnology
Akeso has announced that its new drug application for gumokimab, an IL-17-targeting monoclonal antibody, has been accepted in China. 27 January 2025
Biotechnology
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab). 27 January 2025
Pharmaceutical
Lif, Denmark’s life sciences association, has published an opinion piece urging the government to adopt a stronger political vision for advanced therapies. 27 January 2025
Pharmaceutical
The Food and Drug Administration (FDA) last week granted the first approval for UK pharma major AstraZeneca’s Datroway (Dato-DXd) in the USA for the treatment of breast cancer. On his first day back in the White House as President of the USA, last Monday Donald Trump announced he was pulling the country out of the World Health Organization (WHO). US giant Johnson & Johnson kicked off the fourth-quarter financial results reporting season by big pharma last week, with better-than-expected figures.US mRNA vaccines specialist Moderna announced another supply contract for its COVID-19 vaccine with the European Union (EU). 26 January 2025
Pharmaceutical
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for elamipretide, a first-in-class mitochondria-targeted therapeutic in development for individuals with Barth syndrome. 24 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to NS-051/NCNP-04, which is being developed for the treatment of Duchenne muscular dystrophy (DMD) by Japanese drugmaker Nippon Shinyaku. 24 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Biotechnology
China-based Kelun-Biotech Biopharmaceutical has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody (MAb) tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). 23 January 2025
Pharmaceutical
Regulatory authorities, particularly the US Food and Drug Administration (FDA), have played a crucial role in accelerating and incentivizing the development of innovative treatments through review designations. 23 January 2025
Pharmaceutical
The new US President has repealed an executive order from October 2023, signed by the Biden administration, that sought to establish rigorous safeguards for artificial intelligence (AI) development. 22 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (marketed under trade names including Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). 22 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. 22 January 2025
Biotechnology
T-cell immunotherapy company Atara Biotherapeutics closed 8% lower on Tuesd
ay, having lost 41% of its stock market value on Friday. 22 January 2025
Pharmaceutical
The US Food and Drug Administration has issued a warning letter to French drugmaker Sanofi following an inspection of its Massachusetts manufacturing site. 22 January 2025
Biotechnology
French pharma giant Sanofi has secured European Union approval for Sarclisa (isatuximab) for certain people with newly diagnosed multiple myeloma. 22 January 2025
Generics
This article explores the latest conversations around generic topical and transdermal drug delivery systems (TDS) in the US Food and Drug Administration’s (FDA dermal pharmacology space, delving into recent guidance updates and examining the challenges facing the development of generic TDS. 21 January 2025
Pharmaceutical
US healthcare giant Johnson & Johnson announced the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. 21 January 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. 21 January 2025
Pharmaceutical
French pharma major Sanofi’s consumer healthcare business, Opella, has announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil), for erectile dysfunction (ED), from a prescription to an over-the-counter medicine. 21 January 2025
Pharmaceutical
Swiss pharma giant Novartis has filed a lawsuit against the US Department of Health and Human Services (HHS) over a proposed cash rebate model. 20 January 2025
Pharmaceutical
China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. 30 December 2024
Biotechnology
Johnson & Johnson has secured European approval for Rybrevant (amivantamab) in combination with Lazcluze (lazertinib), as a first-line treatment for certain patients with non-small cell lung cancer (NSCLC). 30 December 2024
Biotechnology
Japanese drugmaker Daiichi Sankyo revealed on Friday that its Datroway (datopotamab deruxtecan; dato-dxd) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. 30 December 2024
Biotechnology
Dutch immunology specialist argenx announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvf) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 30 December 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved nivolumab and hyaluronidase-nvhy, under the trade name Opdivo Qvantig, from US pharma major Bristol Myers Squibb, for subcutaneous injection. 28 December 2024
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
Biotechnology
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
Generics
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Pharmaceutical
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
Pharmaceutical
Denmark has introduced a three-year agreement to regulate price ceilings for hospital medicines, aimed at providing stability for the public healthcare system and pharmaceutical companies. 23 December 2024
Pharmaceutical
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals, to include children as young as two years old. 23 December 2024
Pharmaceutical
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
Biotechnology
Denmark’s Novo Nordisk said late Friday that the US Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection. 22 December 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze