Explore the complete list of our presses below (Page 27 of 27):
AB Science closes EUR 14.2M private placement, reaching ~EUR 23M cash to advance masitinib in ALS and AB8939 in AML. Strategic plan due September 2026.
Ocumension files NCX 470 NDA with China's NMPA using the same Phase 3 dossier as the U.S. FDA submission. Key read for regulatory affairs teams managing multi-jurisdictional dossiers.
Glenmark Pharmaceuticals appoints 30-year veteran Manoj Chitnis as SVP. What the hire signals for GMP compliance and quality leadership strategy.
Biodeal Pharma secures Rs. 385 crore from RMB Capitalworks to enter CIS, Latin America, Africa, and Europe. Implications for GMP compliance and CDMO competition.
Samsung Bioepis launches OPUVIZ aflibercept pre-filled syringe biosimilar across Europe. Key GMP, EMA, and fill-finish implications for QA and regulatory teams.
Innate Pharma plans TELLOMAK-3 Phase 3 and accelerated approval filing for lacutamab in Sézary syndrome, backed by a USD 75M Sobi partnership upfront payment.
Unison Pharmaceuticals names Prasad Mahajan General Manager for quality and manufacturing, reflecting a wider trend of compliance expertise rising to GM level in Indian pharma.
Gland Pharma lands a global CDMO contract targeting $100M annually, covering oncology vials, lyophilised formulations, ampoules, and pre-filled syringes.
Innate Pharma and Sobi sign a USD 580M lacutamab licensing deal to fund TELLOMAK-3 Phase 3 in Sézary syndrome, targeting FDA accelerated approval.
ImmuPharma appoints Kymos Group as bioanalytical CRO for Kapiglucagon, completing a three-vendor outsourced stack as the company targets a 505(b)(2) US pathway.
Merck names Jayesh Parkar as Head of Excipients and Biopharma Chemicals for APAC, targeting commercial growth and stronger manufacturer partnerships across the region.
Veru enrolls 239 patients in Phase 2b PLATEAU trial of enobosarm plus semaglutide, secures Novo Nordisk clinical supply agreement. Interim data due Q1 2027.
Artelo Biosciences doses first patient in Phase 2 DREAM study of synthetic cannabinoid ART27.13 for glaucoma. Initial results expected Q4 2026.
Emergent BioSolutions warns AI and synthetic biology are outpacing biodefense GMP frameworks. Key implications for CDMOs, QA directors, and biosafety protocol leads.
Evotec and Odyssey Therapeutics partner on AI-driven autoimmune drug discovery. Milestone payments tied to validated hit series. No financial terms disclosed.
Zydus launches REVAHALE, India's first once-daily nebulised LAMA for COPD. Key GMP, CDSCO, and device-drug combination implications for QA and regulatory teams.
Ono Pharmaceutical and Mediar Therapeutics partner on antibody discovery for fibro-inflammatory diseases. Explore CMC and manufacturing implications for QA and regulatory leads.
Orion partner Tenax Therapeutics' Phase 3 LEVEL trial of oral levosimendan in PH-HFpEF missed primary endpoints. A Type C FDA meeting and EMA consultation are next.
DiaMedica's DM199 achieves statistically significant blood pressure reductions in Phase 2 preeclampsia trial, setting dose range for regulatory submissions and scale-up planning.
Gland Pharma posts Rs. 1,800 crore revenue in Q1 FY27, up 20% YoY, with PAT rising 47%. Implications for injectable capacity, CDMO growth, and GMP compliance.
DEA proposes moving dual orexin receptor antagonists from Schedule IV to Schedule V. Key compliance implications for daridorexant manufacturers and distributors.
Intensity Therapeutics restarts two paused oncology trials under FDA-reviewed and Swissmedic-approved protocol amendments. Cash position of $9.5M constrains site activation pace.
Fresenius Kabi recalled one lot of Tyenne tocilizumab 400 mg/20 mL vials after glass particles were found. QA teams should review particulate inspection SOPs now.
BC Platforms flags that AI drug development faces an evidence integrity problem, not a data volume problem, with direct implications for FDA submissions and ICH Q10 compliance.
Achieve Life Sciences targets Q4 2026 NDA resubmission for cytisinicline after a cGMP-driven CRL forced a CMO transition to Adare Pharma Solutions. FDA approval expected H1 2027.
Moody's upgrades Teva to Baa3 investment grade following Fitch's May 2026 move. Learn what improved financial flexibility means for Teva's manufacturing and biosimilar pipeline.
Amgen's planned Science and Innovation Center in Hyderabad's Genome Valley will join a seven-site global research network when it opens in 2027.
Bristol Myers Squibb commits $2.3B to a 600,000-sq-ft Houston biologics campus. Key implications for GMP design, process validation, and U.S. reshoring strategy.
Abbott and Google Health sign a multi-year deal integrating Lingo OTC CGM glucose data with AI coaching and a large-scale real-world metabolic health study.
FDA's 2026 lab retest confirms Detoxi Slim contains undeclared sibutramine. QA and regulatory leads should review third-party import controls and supplier qualification programs.
FDA's updated OTC framework and OMUFA FY2026–2030 reauthorization require regulatory affairs teams to audit nonprescription portfolios under the CARES Act monograph system.
Janssen's ICOTYDE gains FDA approval as the first oral IL-23 receptor antagonist for plaque psoriasis, shifting immunology manufacturing demand to OSD capacity.
Codexis advances ECO Synthesis siRNA manufacturing platform toward GMP facility build-out and FDA Emerging Technologies meeting in Q4 2026. Q2 revenue at $14.9M.
Eupraxia Pharmaceuticals reports Q2 2026 results with EP-104GI Phase 1b/2a data showing fibrosis improvement. Phase 3 EoE trial planned for 2027.
Genentech Distinguished Scientist Anwesha Dey is driving AI integration across oncology and cancer biology. Learn how machine learning is reshaping cancer drug discovery at Roche's US affiliate.
Bolt Biotherapeutics advances BDC-4182 ISAC to Cohort 4 at 4.0 mg/kg. Initial Phase 1/2 data due Q3 2026 with $18.1M cash runway into Q1 2027.
Aquestive Therapeutics completes human factors validation and PK studies for Anaphylm, targeting FDA NDA resubmission in Q3 2026 following January 2026 CRL.
Inhibikase Therapeutics secures FDA Orphan Drug Designation for IKT-001 in PAH, adding seven-year exclusivity and tax credits to its Phase 3 IMPROVE-PAH programme.
Mineralys Therapeutics' lorundrostat NDA is under FDA review with a December 22, 2026 PDUFA date. Key implications for QA, regulatory, and supply chain teams.
Madrigal Pharmaceuticals adds J&J R&D chief John C. Reed to its board as Rezdiffra's launch advances and a Phase 3 MASH cirrhosis trial continues.
FDA lab analysis finds undeclared phenolphthalein and yellow oleander derivatives in B. Magi weight-loss supplement, raising adulteration risks under 21 CFR Part 111.
FDA lab analysis confirms DMagic Plus weight-loss supplement contains undisclosed diclofenac and toxic oleander glycosides. QA and regulatory implications reviewed.
FDA's updated Rx-to-OTC switch list includes Rextovy naloxone (June 2026) and Differin Epiduo. Key GMP, labeling, and validation implications for manufacturers.
FDA confirmed undeclared tadalafil in Anaconda Premium 500K supplement. Learn the compliance and patient safety implications for QA and regulatory teams.
Medicus Pharma receives FDA 'Study May Proceed' for SkinJect in Gorlin Syndrome and IRB clearance for Teverelix Phase 2, while disclosing going-concern risk in Q2 2026.
Reviva Pharmaceuticals expects Q4 2026 FDA feedback on a new brilaroxazine formulation before RECOVER-2 Phase 3 enrollment and NDA submission for schizophrenia.
Zealand Pharma secures USD 100 million from Royalty Pharma for rusfertide royalty rights ahead of the Q3 2026 FDA PDUFA date. Takeda retains regulatory and commercial lead.
Atea Pharmaceuticals' C-BEYOND Phase 3 trial met non-inferiority endpoints for BEM/RZR in HCV. Key CMC and NDA implications for QA and regulatory leads.
Kura Oncology's ziftomenib hit $9.1M in Q2 net revenue, up 57%, capturing majority new patient share in R/R NPM1-m AML. KOMET-017 frontline enrollment underway.
NurExone signs binding MOU with Made Scientific for exclusive U.S. GMP exosome manufacturing. First GMP batches targeted H1 2027 from dual FDA/EU Annex 1 facility.
FDA Type A meeting confirms tabelecleucel BLA resubmission pathway via updated ALLELE trial data. Key lessons for regulatory teams navigating CRL responses on single-arm pivotal programs.
Allogene's positive ALPHA3 futility analysis for Cema-Cel in 1L LBCL raises allogeneic CAR-T manufacturing, process validation, and GMP supply chain questions.
Zealand Pharma confirms petrelintide Phase 3 initiation in H2 2026. CDMOs and plant heads face near-term scale-up and sterility assurance demands for the amylin analog.
Cellectar Biosciences targets mid-2027 NDA submission for iopofosine I 131 in Waldenström macroglobulinemia under FDA Accelerated Approval, with Phase 3 site activation underway.
Biomea Fusion doses first OPAL participant in icovamenib-semaglutide obesity combination trial. Key implications for clinical supply chain and API manufacturing teams.
Cabaletta Bio selects ElevateBio as a second CDMO for rese-cel CAR T manufacturing, building ATMP supply chain redundancy ahead of a 2H27 BLA submission.
Bioneeds India names Dr. Girish Joshi as COO as India's pharma exports hit USD 8.1 billion in Q1 FY27. Key implications for contract manufacturing and GMP oversight.
Karyopharm targets August 2026 sNDA submission for selinexor plus ruxolitinib in myelofibrosis under Accelerated Approval. FDA confirmed SVR35 as surrogate endpoint.
ProQR's AX-0810 confirms clinical target engagement for Axiomer RNA editing. Multiple program readouts expected through H1 2027 with EUR 117M cash runway to mid-2028.
FDA's November 2025 approval letter updates BioThrax labeling for post-exposure prophylaxis. Key implications for biologics QA teams and regulatory affairs leads.
AstraZeneca plans to submit CARES subgroup data for anselamimab to regulators after results showed 62% survival improvement in AL amyloidosis patients.
Eledon Pharmaceuticals completes FDA End-of-Phase 2 meeting for tegoprubart, clearing the path for a 600-patient global Phase 3 kidney transplant trial in late 2026.
Eton Pharmaceuticals gains FDA Fast Track for AMGLIDIA, files a PAS for KHINDIVI, and targets a 2027 NDA for ASN-001 as Q2 revenue surges 99% year-over-year.
FDA grants BMS accelerated approval for iberdomide in RRMM. ZENBEXUS REMS now mandatory for specialty pharmacies. Project Orbis review included Swissmedic.
FDA's CTGTAC votes 9-3 against deramiocel for Duchenne cardiomyopathy. BLA 125842 decision due August 22, 2026. Key implications for CGT BLA strategy.
Moleculin's MIRACLE trial shows Annamycin CR rates three times higher than control in AML. Full readout due Dec 2026–Feb 2027, with NDA and scale-up implications.
Gland Pharma names Deepak Sapra as CEO. Learn what the leadership change means for sterile injectable GMP compliance and global regulatory strategy.
FDA approves Lantheus's TAUKLARIFY F18 tau PET agent for Alzheimer's. Key GMP, manufacturing, and supply-chain implications for radiopharmaceutical operators.
NurExone reports MBP-positive cell increases in ExoPTEN preclinical spinal cord study, with implications for exosome CMC strategy and potency assay development.
Abbott India names Dr. Sudarshan Jain as Chairman. With 40+ years in pharma, the appointment signals potential shifts in compliance strategy and manufacturing investment.
China's NMPA accepts CanSinoBIO's NDA for Td5cp adolescent and adult pertussis vaccine. Key regulatory and manufacturing implications for pharma operators.
TCS launches an Agentic AI platform for drug development and pharmacovigilance. QA and regulatory leads should assess ICH Q10, 21 CFR Part 11, and validation requirements.
Aurobindo's Raleigh facility receives FDA VAI classification after 11 Form 483 observations. What the outcome signals for CAPA strategy at US generics sites.
Sun Pharma wins US court ruling dismissing Lipitor antitrust litigation. Key implications for Paragraph IV strategy and Indian generics manufacturers targeting the US market.
PM Modi's call for Indian pharma to reach the global top five raises hard questions about GMP compliance, FDA import alerts, and regulatory harmonization.
Sai Life Sciences elevates Maneesh Pingle to President of Discovery, reinforcing its integrated CRO/CDMO capabilities across drug discovery and development.
Telangana merges food safety and drugs control into TG SAFE. API and formulation manufacturers face tighter, unified enforcement under a single regulatory authority.
J&J's $2.58B acquisition option on Sail Biomedicines targets in vivo CAR T manufacturing, bypassing ex vivo GMP complexity. CMC implications for cell therapy teams.
US FDA approves Lupin's generic Pitolisant tablets as bioequivalent to Wakix. Key implications for QA directors and plant heads in the narcolepsy generics space.
Artelo Biosciences receives U.S. patent allowance for ART27.13's commercial formulation through 2041, with Phase 2 readouts in cancer anorexia and glaucoma due Q4 2026.
Optimus Pharma becomes the first Indian company to receive DCGI approval for Tapinarof cream 1%, an AhR agonist topical. Key implications for regulatory and QA teams.
CBER is advancing biologics regulatory alignment through ICH and APEC RHSC. QA and regulatory leads should understand how convergence reshapes multi-market compliance.
CBER stopped notarizing biologics export certificates in 2014. Regulatory teams must use BECATS for CFG applications and route apostille needs to the State Dept.
FDA reaffirms eHCTERS electronic registration obligations for HCT/P establishments under 21 CFR Part 1271, including annual December updates and 30-day amendment windows.
FDA licenses Emergent BioDefense's CYFENDUS anthrax vaccine under the Animal Rule. Key regulatory and CMC implications for biodefense biologics manufacturers.
FDA and CDC reissue VAERS guidance clarifying NCVIA mandatory reporting obligations for vaccine manufacturers, including Reportable Events Table requirements.
FDA and CDC reaffirm VAERS post-market surveillance reporting requirements for vaccine manufacturers under CBER oversight and 21 CFR Part 600.
Biocon gains FDA approval for Yesintek prefilled autoinjectors. QA and regulatory leads should note combination product, 21 CFR Part 4, and process validation implications.
Coultreon Biopharma names Prista Charuworn MD as CMO to advance SIK3 inhibitor COL-5671 into Phase II for ulcerative colitis and psoriasis. Key implications for QA and CMC teams.
Biocon gains FDA approval for Yesintek ustekinumab-kfce prefilled autoinjector. Key implications for QA, regulatory affairs, and biosimilar combination product strategy.
FDA's generative AI medical device discussion paper proposes risk and premarket frameworks. QA and RA leads in pharma should track implications before the Oct 19 comment deadline.
FibroBiologics reports preclinical cartilage repair in four weeks using FSdCS with a four-day manufacturing cycle. GMP validation and regulatory pathway remain ahead.
Propanc Biopharma initiates Phase 1b feasibility assessment for PRP in solid tumors, with Avance Clinical as CRO and a TGA CTA submission targeted for Q4 2026.
FDA's August 2026 warning letter to Safrel Pharmaceuticals cites no quality unit, no CoAs, no supplier agreements, and inadequate 483 response for OTC drug operations.
FDA issues warning letter to Tianjin Kilo after remote 704(a)(4) review finds process validation failures and drug listing violations at Chinese API facility.
Hearzap completes acquisition of Amplifon India's hearing healthcare business, expanding its clinic network and triggering operational integration across sites.
Novartis India appoints Dr. Chetan P. as Head of Medical, Regulatory and Pharmacovigilance, consolidating compliance functions amid tightening CDSCO oversight.
Novartis presents 10 cardiovascular abstracts at ESC 2026. Phase IV inclisiran and abelacimab data carry manufacturing scale-up and regulatory filing implications for biopharma facilities.