INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2026

Shots: The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively. Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations. The…

3 days ago

The US FDA New Drug Approvals in August 2026

Shots: The US FDA approved seven novel therapies in August 2026, spanning rare diseases, oncology, neurology, hematology, and autoimmune disorders, including Orzeyful (oveporexton), Tauklarify (florquintau F 18), Zenbexus (iberdomide), Pasatru (garetosmab-grts), Rasonque (daraxonrasib), LISRAYA (brepocitinib), and Mimrylo (rusfertide). Key approvals introduced new treatment options across multiple high-unmet-need indications, including narcolepsy type 1, Alzheimer’s disease imaging, relapsed/refractory multiple myeloma, fibrodysplasia ossificans progressiva, metastatic pancreatic ductal adenocarcinoma, dermatomyositis, and polycythemia…

September 8, 2026

Key Biosimilars Events of August 2026

Shots: In August, biosimilar approvals and launches gained strong momentum with Biocon’s Yesafili (Eylea) and Yesintek (Stelara), FDA approval of rituximab from Dr. Reddy’s and Fresenius Kabi, and Celltrion’s European launch of Omlyclo (Xolair). Global licensing and commercialization partnerships continued to drive biosimilar expansion with collaborations spanning North America, Europe, ASEAN, and MENA markets. The biosimilar pipeline continued to broaden across key therapeutic…

September 1, 2026

EMA Marketing Authorization of New Drugs in July 2026

Shots: The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca. EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…

August 18, 2026

The US FDA New Drug Approvals in July 2026

Shots: The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment. Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…

August 11, 2026

Key Biosimilars Events of July 2026

Shots: July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases. Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

August 4, 2026

EMA Marketing Authorization of New Drugs in June 2026

Shots: The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon. European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…

July 21, 2026

The US FDA New Drug Approvals in June 2026

Shots: The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment. Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…

July 14, 2026

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2006-2025)

Shots: PharmaShots' latest report chronicles the transformation of the global biopharma industry from 2006–2025, highlighting how innovation, strategic M&A, AI adoption, and evolving commercialization strategies have reshaped the competitive landscape while companies navigated patent cliffs, pricing pressures, and shifting market dynamics. The report tracks the rise and fall of leading biopharma companies over two decades driven by…

July 10, 2026

Key Biosimilars Events of June 2026

Shots: June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine. Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization. Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion. Celltrion Seeks…

July 7, 2026