Regulatory
Track how regulatory decisions alter competitive positioning, launch timelines, and investor expectations across therapeutic areas.
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REGULATORY
The FDA has approved a supplemental application for Zyrtec Hives, containing cetirizine hydrochloride.
REGULATORY
The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Hikma's Methylprednisolone Sodium Succinate.
COMPETITIVE
Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.
REGULATORY
TEVA Pharmaceuticals has submitted ANDA219413 to the FDA with a standard review priority.
REGULATORY
The FDA has accepted the New Drug Application for BAXFENDY (BAXDROSTAT) from AstraZeneca.
CLINICAL
The EVOLVE study will evaluate the real-world effectiveness of tezepelumab in uncontrolled severe asthma over two years in Greece.
REGULATORY
The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, indicating no clinical need for compounding these drugs.
REGULATORY
Quinacrine is included on the FDA 503B list for compounding, indicating a clinical need for its use in treating cutaneous lupus erythematosus.
REGULATORY
The FDA has issued draft guidance to minimize unnecessary animal testing in the development of cancer drugs.
REGULATORY
The FDA has approved a supplemental application for INQOVI, which contains the active ingredients cedazuridine and decitabine.
REGULATORY
Tebentafusp (IMCgp100) significantly improved overall survival in HLA-A*02:01-positive advanced uveal melanoma, establishing it as a first-line treatment.
REGULATORY
The European Commission has approved ENFLONSIA (clesrovimab) as the first RSV preventive option for infants in the EU.
REGULATORY
The FDA has granted priority review for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for muscle-invasive bladder cancer.
REGULATORY
Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.
REGULATORY
The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.
COMPETITIVE
Antibody-drug conjugates (ADCs) have shown significant clinical benefits in advanced phase trials for various cancers, with over a dozen receiving FDA approval.
REGULATORY
Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.
REGULATORY
The FDA has approved Bizengri (zenocutuzumab-zbco) for the treatment of NRG1 fusion-positive cholangiocarcinoma.
REGULATORY
The FDA granted accelerated approval for Tzield (teplizumab) to delay insulin production decline in pediatric patients with Stage 3 T1D.
REGULATORY
The FDA's ODAC did not reach a majority vote in favor of camizestrant's benefit-risk profile for advanced HR-positive breast cancer.
REGULATORY
Lilly's EBGLYSS® (lebrikizumab-lbkz) is now approved for a maintenance dose every eight weeks, requiring only six injections per year.
REGULATORY
Calderasib (MK-1084) received Breakthrough Therapy designation for first-line treatment of KRAS G12C-mutant NSCLC.
REGULATORY
AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.
REGULATORY
Roche has received CE Mark approval for Elecsys® pTau217, the first blood test designed to detect Alzheimer's disease pathology.
REGULATORY
Roche has received CE Mark approval for Elecsys® pTau217, the first blood test for Alzheimer's disease pathology, enabling faster diagnosis.
Showing 1–25 of 71 records