Explore the complete list of our presses below (Page 28 of 28):
Olympia Pharmaceuticals launches ready-to-use Gonadorelin 1 mg/mL injection across 49 states, expanding its 503B men’s hormone portfolio.
FibroBiologics secures U.S. Patent 12,716,055 for fibroblast conditioned media in degenerative disc disease, with GMP implications for cell therapy CMOs.
FDA updates DSCSA portal requirements, reinforcing electronic traceability, annual reporting and 24-hour illegitimate product notifications.
FDA cites Reliance Life Sciences for falsified microbiology records and LIMS errors at its Navi Mumbai facility, raising serious data integrity concerns.
CDT Equity appoints co-founder James Bligh as CEO following its balance sheet restructuring and acquisition of a 22% stake in Sarborg.
Emcure Pharmaceuticals appoints Anshuman Rai as Associate Vice President, with the functional remit yet to be disclosed.
Elevar presents CARES-310 data at ILCA 2026, showing camrelizumab/rivoceranib survival gains over sorafenib across uHCC age subgroups.
aTyr Pharma reports the FDA's response on its Phase 3 protocol for efzofitimod in sarcoidosis: what was agreed, as the company disclosed it, and timing.
Telix Pharmaceuticals finishes BiPASS Phase 3 enrollment and aligns with FDA on an NDA pathway for 68Ga-PSMA-PET, with GMP scale-up implications for kit makers.
FDA CBER's September 2026 NGS workshop targets analytical validation gaps and ICH Q5A(R2) integration for adventitious agent detection in biologics.
India Glycols demerges its biopharma unit into Ennature Bio Pharma, reporting Rs. 90 crore Q1 revenue and planning BSE/NSE listing. Compliance implications.
Nicox reports €8.4M cash through Q1 2028, with NCX 470's 30 April 2027 PDUFA date as the key milestone for extending operations and royalty revenue into 2029.
Evotec & Plectonic combine BiTco & LOGIBODY® platforms in a preclinical collaboration targeting T cell engager limitations in solid tumors. Key read for CDMOs.
Teva’s TEV-408 meets its primary endpoint in a Phase 2a celiac disease study after a single subcutaneous dose, advancing its clinical development.
AstraZeneca acquires Dizal Pharma, securing global rights to lung cancer drug Zegfrovy and triggering GMP integration and regulatory filing obligations.
Teva is negotiating a Medicaid pricing deal with the Trump administration, with potential implications for generics manufacturers and supply planning.
Novartis suspended its rapcabtagene autoleucel (rap-cel) autoimmune trials after IEC-HS deaths. What the company disclosed and what it means for CAR-T.
FDA CDER issues updated guidance on hepatic impairment PK studies, covering study design, data analysis, and dosing label requirements.
NeuroThera Labs pursues FDA Orphan Drug Designation for SCI-110 in adult Tourette Syndrome, with Phase IIb underway at three global academic centers.
India Glycols demerges its biopharma unit into Ennature Bio Pharma Limited after posting ₹90 crore in Q1 revenue, reshaping QA, CMO and supply chain priorities.
FDA warns foreign clinical trial data may be excluded when sites restrict inspections, raising key GCP compliance risks for regulatory affairs and QA teams.
FDA CDER formalizes the ST&F framework for NDA and BLA safety data review, requiring regulatory teams to align submissions with the Integrated Guide and MAPP.
FDA revoked Moderna's COVID-19 EUA on Aug 27, 2025. QA and regulatory teams must now align Spikevax operations with full BLA, GMP, and ICH Q10 requirements.
FDA revoked Pfizer-BioNTech’s COVID-19 EUA on August 27, 2025. QA teams must align Comirnaty manufacturing with BLA and 21 CFR Part 211.
Inventiva completes last patient visit in NATiV3 Phase 3 trial of lanifibranor for MASH. Topline data Q4 2026; FDA submission planned H1 2027.
WuXi AppTec tracks how oligonucleotide programs targeting muscle, CNS, and lung force CDMOs to rethink conjugate synthesis, purification, and bioanalytical strategy.
Eledon Pharmaceuticals submits FDA IND for tegoprubart in islet cell transplantation and enrolls first patients across four programs ahead of Phase 3 LEGACY trial in Q4 2026.
Cellipont Bioservices reports its Texas CDMO facility supported six cell therapy programs targeting 2026 IND submission, covering GMP manufacturing and regulatory prep.
AbbVie's etentamig met dual primary endpoints in Phase 3 CERVINO for RRMM. What the results mean for sterile manufacturing, fill-finish, and cold chain scale-up.
FibroBiologics secures U.S. Patent 12,721,866 for 3D spheroid fibroblast wound healing. Key GMP and 21 CFR Part 211 implications for cell therapy manufacturers.
AbbVie's $10.9B Apogee acquisition triggers GMP scale-up and technology transfer for half-life extended IL-13 antibody zumilokibart across atopic dermatitis and asthma.
FDA finalizes 2026–2027 influenza vaccine strains across egg-based and cell/recombinant platforms, with key manufacturing and QC implications.
FDA and EMA convene a joint workshop on September 25, 2026, as rising sponsor interest puts botanical drug development and regulatory alignment in focus.
FDA works with six manufacturers to address estradiol patch supply gaps after a 2025 labeling change increased demand, while GMP obligations remain in force.
FDA approves Zanvastro (zilganersen) as the first Alexander disease treatment. Key intrathecal ASO manufacturing and sterility assurance implications for CDMOs.
CBER regulates allergen extracts, patch tests, and antigen skin tests, while potency gaps in non-standardized injectables remain a regulatory issue for firms.
CDA-AMC recommends conditional reimbursement for Yorvipath (palopegteriparatide) in chronic hypoparathyroidism.
Cipla's InvaGen signs a US commercialization deal with Qilu Pharmaceutical for a pembrolizumab biosimilar. FDA inspection & BPCIA timelines are key milestones.
Axcelead's seminar with former FDA senior manager Dr. McGovern clarifies NAMs Road Map implications for IND/NDA non-clinical submissions.
American Regent recalls 3 epinephrine lots over cracked vials and particulate contamination. Key implications for QA directors on sterility assurance and CAPA.
RPGAP acquires Raghava Life Sciences' API business in a 2nd deal following Actis Generics. Key implications for supplier qualification & API sourcing strategy.
Cohance Lifesciences commits $18M to NJ Bio and Aruka Bio to build ADC manufacturing capacity, with both deals closing by September 2026.
Agilent launches ICP-MS, GC systems and a digital lab platform in India as API producers face tighter elemental impurity and data integrity scrutiny from USFDA.
NMPA approves CMS Dermavon's Lumirix topical JAK inhibitor for atopic dermatitis in children from age two, following priority review and Phase III data showing 63% response.
EMA's PRAC has launched a safety referral on injectable iron medicines over hypophosphataemia and osteomalacia risks. Regulatory and QA teams should act now.
EMA registers new EU manufacturing sites for Visudyne (verteporfin), targeting full supply restoration by 2027. A case study in EU shortage governance under the Critical Medicines Act.
Cipla signs a biosimilar deal with Qilu Pharmaceutical to commercialise a pembrolizumab biosimilar in the US. Key regulatory and GMP implications for pharma teams.
AbbVie's etentamig hit dual Phase 3 endpoints in multiple myeloma with a 60% progression risk reduction. Key implications for BLA filing and bispecific manufacturing scale-up.
Weave Bio's AI regulatory submission platform is now live across 14 Takeda drug programs. Key implications for regulatory affairs teams managing multi-program dossiers.
SANOVO Phase III data back Tagrisso-Orpathys in first-line EGFR-mutated NSCLC in China. What label expansion means for NMPA filings and manufacturing scale-up.
Peptides & Complex Generics Symposium 2026 returns to Mumbai with an expanded scientific agenda and the Billion Dose Challenge.
CBER consolidates biologics regulatory resources covering BLA submissions, 21 CFR 600–680, postmarketing compliance, and GMP obligations for QA and regulatory affairs teams.
S&P upgrades Teva to BBB-, completing investment-grade status across all three major agencies. What it means for generics manufacturing and pipeline investment.
Tarsus Pharmaceuticals closes Alkeus acquisition, adding ALK-001, an FDA Breakthrough-designated Phase 3 oral drug for Stargardt disease.
FDA lab analysis found undisclosed sildenafil in ZUBB Dietary Supplement intercepted via international mail. QA teams should review controls.
FDA grants accelerated approval to AstraZeneca's camizestrant with CDK4/6 inhibitors for ESR1-mutated HR+/HER2- metastatic breast cancer, with Guardant360 CDx as companion diagnostic.
FDA grants AstraZeneca accelerated approval for camizestrant in ESR1-mutation breast cancer. First ctDNA resistance-guided approval setspost-market obligations.
Novartis pelacarsen misses primary MACE endpoint in 8,323-patient Lp(a)HORIZON Phase III trial, with implications for ASO manufacturing and Ionis collaboration.
FDA issues immediate compounding guidance after two outsourcing facility shutdowns disrupt neonatal starter parenteral nutrition supply.
Chakravarthi AVPS at GPACTS 2026 urges pharma leaders to prioritize data integrity, AI automation, and serialization to secure India's global regulatory trust.
Rezubio completes first-cohort dosing of inhaled RZ-520 after FDA and NMPA IND clearances, a key update for regulatory and CMO teams managing Phase 1.
Indian Immunologicals submitted batch and distribution records to CDSCO on 14 Aug 2026, denying responsibility for substandard Abhayrab vials found in Delhi.
Fosun Pharma sells ~6% of Gland Pharma for US$294M to fund a HK$1B H-share buyback. What the ownership shift means for Gland's CDMO and injectables operations.
FDA grants AstraZeneca accelerated approval for its breast cancer drug after the SERENA-6 trial reduced disease progression risk by 56%.
Novo Nordisk's STEP Young phase 3 trial met its primary endpoint in children aged 6–12 with obesity. Key data for regulatory and manufacturing teams planning a pediatric semaglutide label.
Pfizer ceases global manufacturing of Minipress XL, triggering regulatory notification duties and supply continuity obligations for QA and regulatory leads across active markets.
Sanofi's three-year partnership with Tricog Health integrates AI cardiac diagnostics into pharma commercial and R&D strategy. Key read for cardiovascular portfolio leads.
HRV Pharma commits Rs. 150 crore to synthetic peptide and high-potency oncology API manufacturing, including a Rs. 40–50 crore capacity underwriting programme.
Cormica consolidates pharma and medical device analytical chemistry at Bradford, providing GMP-aligned integrated testing for combination product manufacturers.
Novartis' Phase III HARBOR study of del-desiran in myotonic dystrophy type 1 missed its primary vHOT endpoint; health authority engagement is underway.
Infex Therapeutics presents Phase IIa RESP-X data at ERS 2026: exacerbation rates fall from 3.4 to 1.2 in Pseudomonas-colonised bronchiectasis patients.
PMV Pharmaceuticals names Philip Herman CCO as it prepares a Q1 2027 NDA for rezatapopt in platinum-resistant ovarian cancer via accelerated approval.
GRI Bio's Phase 2a GRI-0621 data in IPF maps nine mechanistic pillars via RNA sequencing, flow cytometry, and ECM biomarkers, with +99 mL placebo-adjusted FVC at Week 12.
Veru's sabizabulin shows IC50 of 18.2 nM in daraxonrasib-resistant KRAS-mutant pancreatic cancer cells, triggering a planned Phase 2 trial. CMC and supply chain implications inside.
Biocon's consortium wins 100% PDP allocation to supply Pertuzumab to Brazil for 10 years, with technology transfer and dual GMP compliance obligations.
Ocugen doses first patient in ArMaDa3 phase 3 trial of AAV5 gene therapy OCU410 for geographic atrophy, targeting a 2028 BLA via single pivotal trial pathway.
Alkem Laboratories launches Renocia Exo, India's first patented ginsenoside-exosome hair growth serum. Key manufacturing and regulatory implications for QA and formulation teams.
FDA's CBER Refreshed Its General Biologics Guidances Library. QA Directors And Regulatory Leads Should Review The CMC, GMP, & Submission Guidance Clusters Now.
FDA Clarifies CBER NDA/ANDA Jurisdiction Over Blood Processing Solutions, Plasma Expanders, And Anticoagulants For Regulatory Leads.
FDA CBER regulates blood products across BLA, NDA, PMA, and 510(k) pathways. Regulatory teams must align submissions to the correct framework per product.
FDA's latest DDT Qualification Program metrics show 160 projects in development and 22 qualified tools as of July 2026. Key data for regulatory affairs teams.
Inventiva Presents Five Lanifibranor Abstracts At Paris MASH 2026. Phase 1/2 And Preclinical Data Support Pan-PPAR Profile Ahead Of Phase 3 Readout In Q4 2026.
Assembly Biosciences takes 40% U.S. profit-share in Gilead HSV helicase-primase inhibitor program. GS-1179 Phase 2 expected by end of 2026.
Inhibitor Therapeutics proposes surgically eligible BCCs as primary endpoint and seeks FDA guidance on external control use for its itraconazole BCCNS program.
Neurizon names Dr. Chris Bremer CEO to lead drug development and commercialisation. Read the operational implications for pipeline-stage biotech.
Elix & Axcelead DDP formalise a collaborative research agreement combining generative AI with targeted protein degrader expertise to tackle undruggable targets.
Rezubio doses first patients in Phase I trial of inhaled drug RZ-520. The trial evaluates pulmonary exposure and inhalation manufacturing compliance.
Onyx Scientific invests £1.5M to add four GMP suites at its UK API site, raising total capacity to ten suites for contract API manufacturing.
ProBioGen and Transgene expand their CDMO collaboration to improve viral vector manufacturing productivity and reduce costs across Transgene's pipeline.
Just Evotec Biologics starts Phase 1 for JST-018 mAb cocktail under a US DoW contract. The orthopoxvirus treatment is made via continuous processing.
CDSCO shifts to risk-based drug approvals to ease compliance. QA & regulatory leads: track these new framework updates before adjusting India strategies.
FDA grants accelerated approval to Bayer's sevabertinib for first-line HER2-mutant NSCLC. Reviewed under Project Orbis with MHRA. Key facts for regulatory and QA leads.
Cellipont Bioservices and Xiogenix publish white paper on ARES™ X20+ fill-finish platform, showing consistent GMP performance across a 17-fold cell therapy scale increase.
Propanc Biopharma plans a February 2027 first-in-human Phase 1b study of PRP in solid tumors, with parallel GMP manufacturing, bioanalytics, and HREC submission underway.
ProQR Therapeutics doses first healthy volunteer in Phase 1 study of AI-discovered RNA editing candidate AX-0811 for cholestatic liver disease. Data expected January 2027.
FDA OTAT's inaugural gene therapy CMC town hall sets expectations for IND & BLA submissions. Key takeaways for plant heads, QA directors, and regulatory leads.
Novo Nordisk's REBINYN approval (STN 125611) sets a regulatory benchmark for GlycoPEGylated biologics. Key reference for QA and regulatory affairs leaders.
FDA re-surfaces ICH M3(R2) nonclinical safety guidance under docket FDA-2008-D-0470. Regulatory teams should audit IND and NDA study packages for alignment.
Ritedose names Carolyn Berg VP of Strategic Growth, expanding its sterile BFS CDMO commercial strategy in ophthalmic and respiratory manufacturing markets.
Sarborg applies quantum computing and Signature Intelligence to neuropsychiatric drug discovery. CDT Equity holds 22.7% stake. What R&D and regulatory teams should know.
Medicus Pharma posts abridged Phase 2 CSR for SkinJect, confirming 200 µg D-MNA patch as pivotal dose for FDA-authorized Gorlin syndrome NDA program.
FDA grants Priority Review for Roche's Enspryng sBLA in MOGAD. Phase III METEOROID showed 68% relapse reduction. Decision due 10 January 2027.
FDA's September 2026 final order removes PABA and trolamine salicylate from OTC Monograph M020. SPF limits and labeling provisions remain open for future orders.
AbbVie's Phase 3 LUNA study shows atogepant met all endpoints in menstrual migraine. Explore CMC, regulatory, and scale-up implications for QA and ops teams.
Cosette Pharmaceuticals names Andrew Adams VP of Supply Chain & Sourcing to strengthen supplier governance and launch readiness as its sterile portfolio expands.
FDA OTAT's first gene therapy CMC town hall clarifies IND, BLA, and NDA submission expectations for advanced therapy manufacturers. Transcript now available.
FDA clears Roche cobas Malaria NAT test for individual donor screening on cobas 6800/8800. Key implications for blood banks, QA systems, & transplant programs.
Medical Action Industries issues a Class I correction for 16 epidural kit lots after a Huons sterility failure cascaded through Spectra Medical Devices.
A joint FDA-NIH-CDC workshop examines regulatory pathways and manufacturing gaps for Valley fever vaccines, with implications for biologics developers & CMOs.
XORTX begins GMP contract manufacturing of XORLO™ oxypurinol, structuring clinical supply batches to simultaneously build NDA validation and stability data.
Axcelead presents salivary biomarker data as a rodent surrogate for GLP-1 nausea liability at the 2026 JSSO/JSTO joint meeting.
China's NMPA has accepted Nicox's NCX 470 glaucoma NDA for review. A regulatory decision is expected within 12–18 months.
Lonza's New Oregon Spray-Drying Facility Targets Amorphous Solid Dispersion Manufacturing, Addressing CDMO Capacity Gaps For Poorly Soluble Compounds.
FDA extends Joenja (leniolisib) approval to children aged 4–11 with APDS using PK bridging data. Key regulatory read for rare disease and pediatric extension sponsors.
CPHI Milan Pharma Awards 2026 finalists announced, recognizing excellence in API innovation, digital transformation, manufacturing, supply chain & leadership.
Bespak and Upperton partner to accelerate nasal drug development, integrating formulation, device and manufacturing for CNS delivery.
Telix ITM radiopharma merger combines isotope manufacturing, pipeline strength and global commercial delivery capabilities.
Pharma Now introduces Inside CDMO: Behind the Glass, a podcast series featuring candid conversations with global CDMO leaders on biologics, consolidation, and sustainability.
In the Inside CDMO premiere, HIPRA Biotech's Eduard Viladesau shares his journey from BCG to launching a CDMO, securing first client in 9 months at CPHI Milan.
Kyverna Therapeutics reports durable one-year KYSA-8 and KYSA-6 data for miv-cel in SPS and gMG, supporting a Q4 2026 rolling BLA submission.
Nuvectis secures China CDE Breakthrough Therapy Designation for NXP200 in BRAF-mutant high-grade glioma, with a U.S. IND submission targeted for Q4 2026.
ADARx Pharmaceuticals prices upsized IPO at $17/share, securing $535M combined with AbbVie's 4.9% private placement.
Elicio presents Phase 2 ELI-002 data at ESMO 2026. Important Phase 3 manufacturing and CMC readiness implications for pancreatic cancer teams.
Becton Dickinson issues Class I correction for kits with recalled Huons sodium chloride ampules. Key supply chain and QA impacts for pharma operators.
FDA resolves four-year albuterol shortage. Ritedose expands BFS production and wins new strength approval. Vital read for hospital formulary & QA teams.
FDA opens comment period for BsUFA reauthorization covering FY2028–2032. Public meeting October 26, 2026; docket FDA-2015-N-3326 closes November 25.
FDA approved Merck’s belzutifan + lenvatinib for ccRCC on Sept 24, 2026. Teams must review Assessment Aid data, key labeling, and boxed warnings.
FDA placed Zenzi Pharmaceutical on Import Alert 66-79 after three unanswered section 704(a)(4) records requests.
FDA approves Onswik (insulin efsitora alfa-gobe), the second once-weekly basal insulin for type 2 diabetes. Key implications for fill-finish facilities & CMOs.
Inventiva's Phase 3 NATiV3 trial for lanifibranor in MASH reports topline data in Q4 2026. H1 2026 R&D spend hit €46.2M as commercial prep accelerates.
Oryzon Genomics secures EMA Clinical Trial Authorisation for HOPE-2, a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome.
FDA's January 2026 warning letter to Boothwyn Pharmacy details ISO 5 airflow failures, subpotent GLP-1 injectables, and a distributed sterility failure.
FDA approves Teva's DEGEVMA biosimilar to Xgeva. Combined with PONLIMSI, Teva completes a dual denosumab biosimilar portfolio ahead of U.S. launch.
Novo Nordisk signs a $2.6B license with Hengrui Pharma for oral GLP-1/GIP HRS-1596, raising manufacturing & technology transfer questions for QA/plant.
AB Science revises its AB8939 AML and masitinib ALS trial timelines after a five-day, three-authority for-cause GCP inspection prompted a QMS overhaul.
FDA's 2026 warning letter to Curia New York details thousands of undocumented HPLC injections and Developer-role misuse in Empower, triggering API adulteration findings.
FDA designates Kellin Chemicals API as adulterated after inspection refusal. U.S. drug manufacturers sourcing from the Zhangjiagang site face import detention and 301(c) exposure.
FibroBiologics secures European Patent No. 3568465 covering fibroblast conditioning with PRP and cytokines for spinal disc regeneration and angiogenesis.
NewAmsterdam Pharma doses first participant in SPINOZA Phase 2b trial of obicetrapib in preclinical Alzheimer's disease with genotype-stratified, biomarker-driven design.
Propanc Biopharma advances GMP manufacture, PK validation, and HREC submission in parallel ahead of a Q1 2027 Phase 1b first-in-human PRP study in solid tumors.
AbbVie partners with Valkai on AI-driven clinical development, aiming to streamline research workflows and accelerate drug development timelines.
FDA's Center for Veterinary Medicine issued a warning letter to Epicur Pharma over misbranded compounded animal drug claims, a key compliance signal for 503B outsourcing facilities.
Moleculin Biotech closes Part A enrollment in its Phase 2/3 AML MIRACLE trial at 89 subjects, targeting a Q1 2027 comprehensive data readout for AnnAraC.
Phathom Pharmaceuticals launches a Phase 3 trial of vonoprazan for as-needed treatment of non-erosive GERD, advancing its clinical development.
FDA approves AbbVie's JUVMO as the first selective D1/D5 receptor agonist for Parkinson's disease. Key regulatory and CMC implications for CNS pipeline sponsors.
Pfizer presents 45 oncology studies at ESMO 2025 Madrid, including 11 oral sessions. CDMOs and manufacturers should assess pipeline-to-plant implications now.
Akums secures a first-in-India DCGI approval for Colchicine in cardiovascular use, signalling growing regulatory momentum in India's cardiology generics sector.
FDA cited Bentley Laboratories for OOS investigation failures under 21 CFR 211.192 and two unapproved OTC drugs. Seizure or injunction risk flagged.
FDA's CDER issued Warning Letter MARCS-CMS 735876 to Celmade for selling unapproved injectable botulinum toxin into the U.S. market. Key enforcement read for regulatory teams.
FDA warns Fresenius Kabi AG over CGMP investigation failures at its Melrose Park sterile injectables site, including a famotidine recall tied to patient pyrogenic reactions.
Medicus Pharma submits a seamless Phase 2b/3 FDA protocol for Teverelix, cutting planned enrollment to ~600 patients ahead of out-licensing the APC program.
CHMP upholds negative opinion on Xervyteg® after re-examination. MaaT Pharma schedules FDA CMC pre-IND for MaaT034 and advances PHOENIX Phase 3 trial design.
Zealand Pharma's petrelintide achieved 10.7% weight loss in Phase 2 ZUPREME-1. Phase 3 trials are underway, raising scale-up and process validation questions.
Telix Gains FDA Fast Track For BiPASS Prostate Cancer PET Program With Planned NDA Submission Impacting Radiopharmaceutical GMP And CMC Manufacturing
FDA and DOJ charge two Indian nationals in a counterfeit Ozempic scheme. QA directors and plant heads face urgent DSCSA and distributor due diligence questions.
FDA And CRCG Host Two Day LAI Generics Workshop Dec 1-2 2026 Covering IVRT Bioequivalence ANDA Deficiencies And Model Integrated Evidence For Complex Injectable
Novo Nordisk Licenses Hengrui's Oral GLP-1 For $2.6B, Altering The Weight-Loss Sector. Boosts Solid-Dose CMO Demand & Sets The High Bar For Oral GMP Compliance.
Indirect ACHIEVE-3 vs PIONEER PLUS analysis favours Lilly's Foundayo on weight loss. Key implications for regulatory strategy and GMP manufacturing planning.
AstraZeneca acquires a 12% stake in Summit Therapeutics for $2 billion to co-develop ivonescimab. Key implications for biologics manufacturing & CDMO capacity.
AbbVie's zumilokibart met EASI-75 primary endpoint in Phase 2 APEX Part B. Mid-dose advances to Phase 3, triggering mAb scale-up and fill-finish planning.
FDA accepts Roche's NDA for fenebrutinib under Priority Review for RMS and PPMS. First BTK inhibitor filing across both MS indications.