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CHENGDU, CHINA
JUL 30, 2026
NMPA

NMPA accepts Kelun-Biotech's sac-TMT for first-line advanced TNBC

China's National Medical Products Administration (NMPA) accepted Kelun-Biotech's supplemental new drug application for sacituzumab tirumotecan (sac-TMT), a TROP-2-directed antibody-drug conjugate, as first-line treatment for adults with locally advanced or metastatic triple-negative breast cancer. sac-TMT was previously approved in China for pretreated advanced TNBC and non-squamous NSCLC. Gilead holds ex-China rights to sac-TMT through a 2024 partnership; the China 1L TNBC filing is Kelun's independent regulatory activity.

/ Oncology, TNBC, TROP-2 ADC
DATELINE HEADLINE
PETACH TIKVA, ISRAEL
JUL 29, 2026
FDA

PolyPid's D-PLEX100 NDA accepted with Priority Review for surgical site infection prevention

FDA accepted PolyPid's New Drug Application for D-PLEX100 with Priority Review designation. D-PLEX100 is a locally delivered biodegradable polymer-lipid matrix that releases doxycycline directly at the surgical site over a controlled multi-week window, intended to prevent surgical site infections in abdominal colorectal surgery. Priority Review shortens the review clock to six months from the standard ten.

AMSTERDAM
JUL 24, 2026
EMA

CHMP recommends 12 new medicines for approval

EMA's CHMP recommended 12 new medicines for approval at its 20-23 July 2026 meeting — 8 novel branded products (including three lipid-lowering approvals on the same day, Susvimo's port delivery implant, and the first oral IL-23R antagonist), one COVID-19 post-exposure antiviral, and three generics.

COPENHAGEN
JUL 23, 2026
FDA

Lundbeck's Lu AH69593 wins Fast Track designation for narcolepsy

FDA granted Fast Track designation to Lundbeck's Lu AH69593, an investigational oral orexin 2 receptor agonist, for the treatment of narcolepsy. Orexin 2 signalling drives wakefulness; Lundbeck is one of several sponsors (Takeda, Centessa, Alkermes) pursuing OX2R agonism as a mechanism-targeted approach to narcolepsy type 1 (orexin-deficient) and adjacent hypersomnias.

PALO ALTO, CALIFORNIA
JUL 22, 2026
FDA

BridgeBio's encaleret NDA accepted for autosomal dominant hypocalcemia type 1

FDA accepted BridgeBio's New Drug Application for encaleret, an oral calcium-sensing receptor antagonist, in autosomal dominant hypocalcemia type 1 (ADH1), with a PDUFA target action date of May 8, 2027. FDA is not currently planning to hold an advisory committee. If approved, encaleret would become the first therapy specifically indicated for ADH1, a rare genetic form of hypoparathyroidism driven by gain-of-function CASR mutations.

LONDON, UK
JUL 10, 2026
FDA

Ris-Rez meets Phase III OS endpoint in small-cell lung cancer

GSK's licensor Hansoh Pharma reported positive Phase III ARTEMIS-008 topline: risvutatug rezetecan (Ris-Rez) improved overall survival vs topotecan in advanced/relapsed SCLC (China patient population). Ris-Rez, a B7-H3-targeted ADC licensed to GSK ex-Greater-China, holds two FDA Breakthrough Therapy Designations (r/r ES-SCLC + r/r osteosarcoma) and an EMA PRIME designation for r/r ES-SCLC.

LONDON
JUL 07, 2026
MHRA

Kygevvi (doxecitine + doxribtimine) authorised for thymidine kinase 2 deficiency

MHRA authorised UCB's Kygevvi (doxecitine + doxribtimine) as the first treatment for paediatric and adult patients with thymidine kinase 2 deficiency (TK2d) with age of symptom onset on or before 12 years. TK2d is an ultra-rare mitochondrial disease that impairs the maintenance of mitochondrial DNA in muscle and produces progressive skeletal muscle weakness — historically with no approved disease-modifying therapy.

AMSTERDAM
JUL 07, 2026
EMA

EMA starts phased review of daraxonrasib for previously-treated metastatic pancreatic cancer

EMA's Committee for Medicinal Products for Human Use (CHMP) has initiated a phased review of Revolution Medicines' daraxonrasib for the treatment of metastatic pancreatic cancer in patients who have received prior treatment. Phased review is EMA's accelerated-assessment path in which data are evaluated as they become available, compressing overall timeline. The decision was made on the basis of a Phase 3 study published in the New England Journal of Medicine comparing daraxonrasib to chemotherapy, in a patient population with a life expectancy of about 6 months after prior-line progression.

CANTON, MASSACHUSETTS
JUL 06, 2026
FDA

FDA accepts Organogenesis's ReNu BLA for symptomatic knee osteoarthritis

FDA accepted Organogenesis Holdings's Biologics License Application for ReNu — a cryopreserved amniotic suspension allograft — for the management of pain in symptomatic knee osteoarthritis. The PDUFA target action date is set for April 24, 2027. If approved, ReNu would be the first FDA-approved non-surgical biologic therapy for knee OA, an indication with ~31 million U.S. patients and no regenerative-therapy incumbent.

ZUG, SWITZERLAND
JUL 06, 2026
FDA

FDA accepts Pharvaris's deucrictibant NDA for on-demand HAE treatment

FDA accepted Pharvaris's New Drug Application for deucrictibant immediate-release (20 mg) for the on-demand treatment of hereditary angioedema (HAE) attacks in patients 12 years and older. The PDUFA target action date is set for April 23, 2027. Deucrictibant is a novel, potent, orally bioavailable small molecule bradykinin B2 receptor antagonist — a mechanism-of-action that would be unique among oral on-demand HAE treatments if approved.

LONDON
JUL 06, 2026
MHRA

Zynyz authorised for advanced Merkel cell carcinoma

MHRA authorised Incyte's Zynyz (retifanlimab) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. Zynyz is a humanised anti-PD-1 monoclonal antibody previously FDA-approved for this indication in March 2023; the UK authorisation adds the second major-market approval for a treatment class that has substantially reshaped outcomes in an aggressive skin cancer historically treated with chemotherapy.

MALMÖ
JUL 03, 2026
FDA

CRL issued for Ascelia's Orviglance NDA in liver-MRI

FDA issued a Complete Response Letter for Ascelia Pharma's Orviglance (manganese chloride tetrahydrate) NDA for contrast-enhanced liver MRI in patients with severe kidney impairment, citing deficiencies in clinical data (image reading process) and product documentation.

LONDON
JUL 03, 2026
MHRA

Wegovy authorised for MASH with moderate-to-advanced liver fibrosis

MHRA granted conditional marketing authorisation to Novo Nordisk's Wegovy (semaglutide 2.4 mg weekly injection) for adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis. This is the first UK approval of a GLP-1 receptor agonist for MASH — a chronic liver disease historically without a marketed pharmacological treatment — and extends Wegovy beyond its established weight-management and cardiovascular-risk-reduction indications.

SILVER SPRING
JUL 01, 2026
FDA

Casgevy cleared for pediatric sickle cell disease and β-thalassemia

FDA issued a supplemental approval expanding Casgevy (exagamglogene autotemcel) to patients aged 2 years and older with sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia. Casgevy was previously approved for ages 12+, and this becomes the first gene therapy approved for patients as young as 2 with SCD.

MENLO PARK, CA
JUN 30, 2026
FDA

Tregzi cleared for matched-donor HSCT in hematologic malignancies

FDA approved Orca Bio's Tregzi for adult patients undergoing matched-donor allogeneic hematopoietic stem cell transplantation with a myeloablative preparative regimen — the first precision-engineered allogeneic regulatory T cell therapy authorized in the U.S. Approval covers hematopoietic and immunologic reconstitution and improvement of chronic graft-versus-host-disease-free survival.

LOS ALTOS, CA
JUN 30, 2026
FDA

Unicycive receives CRL for oxylanthanum carbonate

FDA issued a Complete Response Letter to Unicycive Therapeutics for the resubmitted NDA of oxylanthanum carbonate (OLC) in hyperphosphatemia. FDA cited the same third-party manufacturing deficiencies flagged in the June 2025 CRL and confirmed no clinical efficacy or safety concerns were raised; the agency's inspection of the third-party vendor had not been conducted as part of this review cycle.

SILVER SPRING
JUN 29, 2026
FDA

FDA publishes Expanded Access Q&A webinar materials

FDA's CDER Small Business and Industry Assistance (SBIA) program has published the materials from its April 15, 2026 webinar on the Expanded Access pathway for investigational drugs. The session covers the three EA categories (individual patient, intermediate-size population, treatment INDs and protocols) along with submission requirements, sponsor responsibilities, and common misconceptions.

BOSTON
JUN 29, 2026
FDA

PDUFA extended for Praxis relutrigine in SCN2A / SCN8A developmental and epileptic encephalopathies

FDA extended by three months the review period for Praxis Precision Medicines's relutrigine NDA, updating the PDUFA target action date from September 27, 2026 to December 27, 2026. Praxis submitted additional sensitivity analyses of existing clinical data, which FDA classified as a 'major amendment'. FDA raised no new safety or manufacturing concerns and requested no additional clinical studies.

FRANKFURT, GERMANY
JUN 29, 2026
FDA

Xeomin cleared for pediatric upper limb spasticity in cerebral palsy

FDA approved Merz Therapeutics' Xeomin (incobotulinumtoxinA) for the treatment of upper-limb spasticity in pediatric patients aged 2 and older with cerebral palsy. Xeomin was previously approved for adult upper-limb spasticity in 2010; this label expansion extends the indication into the largest population for which upper-limb spasticity intervention is prescribed.

SILVER SPRING
JUN 26, 2026
FDA

AdComm meeting scheduled for Capricor's deramiocel

FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet July 29, 2026 to review Capricor's BLA 125842 for deramiocel, an allogeneic cardiosphere-derived cell therapy for Duchenne muscular dystrophy. PDUFA target action date is August 22, 2026.

AMSTERDAM
JUN 26, 2026
EMA

CHMP recommends label expansions for 12 medicines

EMA's CHMP issued positive opinions for therapeutic-indication extensions on 12 already-authorised medicines at its 22-25 June 2026 meeting, including expansions for Rinvoq, Stelara, Tecvayli, Datroway, Leqvio, Jaypirca, Opzelura, Imvanex, Menquadfi, Rezolsta, and Symtuza.

STOCKHOLM
JUN 26, 2026
FDA

CRL issued for Sobi's NASP BLA in uncontrolled gout

FDA issued a Complete Response Letter for Sobi's NASP (nanoencapsulated sirolimus + pegadricase) BLA in adults with uncontrolled gout, citing deficiencies at contract manufacturing facilities and additional data on the biologic manufacturing control strategy — no clinical efficacy or safety concerns were raised.

WOBURN, MA
JUN 26, 2026
FDA

FDA accepts Replimune's RP1 BLA resubmission as Class 1 with Aug 2 PDUFA

FDA accepted Replimune's resubmission of the RP1 (vusolimogene oderparepvec) Biologics License Application for advanced melanoma as a Class 1 complete response with a PDUFA target action date of August 2, 2026. FDA notified Replimune to expect an advisory committee meeting in late July. This reverses course after the initial April 2026 review cycle that culminated in a CRL.

LOUISVILLE, KENTUCKY
JUN 22, 2026
FDA

Tecelra converts to full FDA approval and expands to pediatric synovial sarcoma

FDA converted Tecelra's 2024 accelerated approval to full (traditional) approval and expanded the indication to include patients as young as 12 years — the first engineered T-cell therapy for a solid tumour approved for a paediatric population. Full approval was granted on the basis of the SPEARHEAD-1 confirmatory Phase 2 trial (n=137) which produced an overall response rate of 43.8% (complete responses 3.6%) in HLA-A*02-eligible, MAGE-A4-expressing advanced synovial sarcoma. Sponsor is US WorldMeds, which acquired Tecelra's U.S. commercial rights from Adaptimmune.

RAHWAY, NJ
JUN 18, 2026
FDA

Capvaxive cleared for pediatric pneumococcal disease

FDA approved Merck's Capvaxive (21-valent pneumococcal conjugate vaccine) for children and adolescents aged 2-17 at increased risk for pneumococcal disease. The approval expands Capvaxive from its original adult indication into the pediatric high-risk population.

ISELIN, NEW JERSEY
JUN 16, 2026
FDA

FDA accepts Outlook Therapeutics's resubmitted BLA for LYTENAVA in wet AMD

FDA acknowledged receipt of Outlook Therapeutics's resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for neovascular (wet) age-related macular degeneration. The resubmission is a Class 1 review with a PDUFA target action date of July 29, 2026 — approximately three weeks out. If approved, LYTENAVA would be the first and only ophthalmic formulation of bevacizumab with FDA-approved labelling and standardised manufacturing, replacing the off-label use of oncology-formulation Avastin that currently dominates the wet-AMD anti-VEGF injection market.

WHIPPANY, NJ
JUN 15, 2026
FDA

Ambelvist cleared for MRI contrast enhancement

FDA approved Bayer's Ambelvist (gadoquatrane) for use with contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions. Ambelvist is dosed at 0.01 mmol/kg — the lowest-dose macrocyclic gadolinium-based contrast agent ever approved in the United States.

FOSTER CITY, CALIFORNIA
JUN 15, 2026
FDA

FDA accepts Gilead's sNDA for once-weekly oral Yeztugo for HIV PrEP

FDA accepted Gilead Sciences's supplemental New Drug Application for Yeztugo (lenacapavir) 300 mg tablet as a once-weekly oral formulation for HIV pre-exposure prophylaxis (PrEP). PDUFA target action date is February 2, 2027. If approved, once-weekly oral Yeztugo would be the first long-acting oral PrEP option — filling the middle ground between the current daily-oral standard-of-care (F/TDF, F/TAF) and Gilead's own twice-yearly subcutaneous lenacapavir (Yeztugo injection, approved 2025). The submission is supported by the established clinical profile of lenacapavir in PrEP from the PURPOSE 1 and PURPOSE 2 Phase 3 trials.

RAHWAY, NJ
JUN 12, 2026
FDA

Keytruda and Keytruda Qlex cleared for adjuvant clear cell renal cell carcinoma

FDA approved Keytruda (pembrolizumab, IV) and Keytruda Qlex (pembrolizumab + berahyaluronidase alfa-pmph, subcutaneous), each in combination with Welireg (belzutifan), for adjuvant treatment of adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy. This is the first approved combination of a PD-1 inhibitor and a HIF-2α inhibitor.

CAMBRIDGE, MA
JUN 02, 2026
FDA

Cavhanza cleared for Philadelphia chromosome-positive CML

FDA approved Cavhanza (nilotinib) orally disintegrating tablets from Cycle Pharmaceuticals for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). The ODT formulation is designed to be taken without regard to meals or acid-reducing agents (PPIs and H2 antagonists), removing the food-effect and drug-interaction restrictions that constrain the reference-listed nilotinib product (Tasigna).

CHENGDU, CHINA
JUN 01, 2026
FDA

Cypsedo (cipepofol) cleared for general anesthesia

FDA approved Cypsedo (cipepofol) injection from Haisco Pharmaceutical Group for general anesthesia. Cipepofol is a short-acting GABA-A positive allosteric modulator ~4-6× more potent than propofol, and Cypsedo is the first China-originated innovative intravenous anesthetic to receive FDA marketing authorization.

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